Randomized Control Trial of Fluid Therapy for Pediatric D... | NCT01365793

ID	Type	Description	Link
U01HD062417	U.S. NIH Grant/Contract		View source

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Label	Type	Description	Intervention Names
Rapid rehydration using 0.45% saline replacement fluid	Experimental	This arm will involve more rapid intravenous fluid treatment which will include a second 10cc/Kg bolus of 0.9% saline and assume a 10% fluid deficit. 0.45% saline will be used as the replacement fluid for this arm.	Drug: 0.45% saline replacement fluid
Rapid rehydration using 0.9% saline replacement fluid	Experimental	This arm will involve more rapid intravenous fluid treatment which will include a second 10cc/Kg bolus of 0.9% saline and assume a 10% fluid deficit. 0.9% saline will be used as the replacement fluid.	Drug: 0.9% saline replacement fluid
Slower rehydration using 0.45% saline intravenous fluid	Experimental	This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fluid bolus) with 0.45% saline used as the replacement fluid.	Drug: 0.45% saline intravenous fluid
Slower rehydration using 0.9% saline intravenous fluid	Experimental	This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fuid bolus) with 0.9% saline used as the replacement fluid.	Drug: 0.9% saline Intravenous fluid

Name	Type	Description	Arm Group Labels	Other Names
0.45% saline replacement fluid	Drug	10cc/Kg bolus of 0.9% saline followed by 0.45% saline used as the replacement fluid	Rapid rehydration using 0.45% saline replacement fluid

Measure	Description	Time Frame
the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)	The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.	24 hours

Measure	Description	Time Frame
Frequency of Clinically Apparent Brain Injury	Deterioration in neurological status requiring interventions such as hyperosmolar therapy or endotracheal intubation, or resulting in death. This outcome was determined by an adjudication committee.	24 hours
Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)

Name	Affiliation	Role
Nathan Kuppermann, MD, MPH	University of California, Davis	Principal Investigator
Nicole S Glaser, MD	University of California, Davis	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Davis		Sacramento	California	95817	United States
Children's Hospital Colorado

PubMed Identifier	Type	Citation	Retractions
23490311	Background	Glaser NS, Ghetti S, Casper TC, Dean JM, Kuppermann N; Pediatric Emergency Care Applied Research Network (PECARN) DKA FLUID Study Group. Pediatric diabetic ketoacidosis, fluid therapy, and cerebral injury: the design of a factorial randomized controlled trial. Pediatr Diabetes. 2013 Sep;14(6):435-46. doi: 10.1111/pedi.12027. Epub 2013 Mar 13.

Label	URL
Official website of the Pediatric Emergency Care Applied Research Network (PECARN), funded by HRSA/MCHB	View source

ID	Title	Description
FG000	Rapid Rehydration Using 0.45% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.

ID	Title	Description
BG000	Rapid Rehydration Using 0.45% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
BG001	Rapid Rehydration Using 0.9% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
BG002	Slower Rehydration Using 0.45% Saline Replacement Fluid	This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
BG003	Slower Rehydration Using 0.9% Saline Replacement Fluid	This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000344 BG001351 BG002345 BG003349 BG0041389

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)

The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.

Patients with a GCS of 14 or 15 at randomization

Posted

Count of Participants

Participants

24 hours

ID	Title	Description
OG000	Rapid Rehydration Using 0.45% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
OG001	Rapid Rehydration Using 0.9% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
OG002	Slower Rehydration Using 0.45% Saline Replacement Fluid	This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
OG003	Slower Rehydration Using 0.9% Saline Replacement Fluid	This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.

Units	Counts
Participants	OG000337 OG001345 OG002338 OG003

Title

Denominators

Categories

Title	Measurements
	OG00010 OG00111 OG00211 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	The study uses a factorial experimental design, and tests two null hypotheses. The first of these hypotheses - the frequency of GCS score declines to <14 is equal between the Rapid Rehydration and Slower Rehydration groups - is reported here. The analysis of the second hypothesis is reported below.	Cochran-Mantel-Haenszel		0.34	The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.													Superiority

Secondary

Frequency of Clinically Apparent Brain Injury

Deterioration in neurological status requiring interventions such as hyperosmolar therapy or endotracheal intubation, or resulting in death. This outcome was determined by an adjudication committee.

All randomized patients.

Posted

Count of Participants

Participants

24 hours

ID	Title	Description
OG000	Rapid Rehydration Using 0.45% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
OG001	Rapid Rehydration Using 0.9% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
OG002	Slower Rehydration Using 0.45% Saline Replacement Fluid

Secondary

Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)

The Digit Span subtest is adapted from the Wechsler Intelligence Scale for Children, 4th version (WISC-IV) and it assesses working memory. It consists of a Digit Span Forward task in which individuals are asked to repeat numbers in the same sequence as they were presented verbally and a Digit Span Backward task in which participants repeat the numbers in the reversed order to which they were heard. Each task yields a score ranging from 0 to 16. Higher scores represent better outcomes for this test. The trajectory of digit span scores during the course of the hospitalization was used to assess improvements in mental status and whether these varied systematically as a function of treatment protocol. Digit span measurements were collected every four hours during waking hours (7AM to 10PM). The measure analyzed is the average linear change in scores between enrollment and either 24-hours or DKA resolution, whichever occurred first.

All randomized patients with digit span measured during DKA

Posted

Mean

Standard Error

Digit Span Change per Hour

24 hours

ID	Title	Description
OG000	Rapid Rehydration Using 0.45% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.

Secondary

Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA.

Contextual memory was assessed via color and spatial-position tasks. Color-Task: black-ink items on a white square background were shown on a computer screen with a colored border. Subjects were asked to remember the item and the item's border color. Items were shown for 1 second, followed by a 1-second interval in which a fixation point was shown. Then, subjects were given a self-paced recognition test including studied drawings and new drawings shown in random order with no color border. Subjects determined if they had seen the drawing before. For recognized drawings, subjects reported the previously shown border color. Spatial-Position task: identical to the color task except that the items instead varied in their spatial position on the computer screen. The item-context association rate is the rate of correct item-color and item-spatial position recalled over the total of previously viewed items correctly recognized. Score range: 0-1 with higher scores indicating a better outcome.

All randomized subjects aged 6 years old and older with 3-month follow-up and successful completion of memory score tests, and d-prime (a measure of chance agreement) >0.50

Posted

Mean

Standard Deviation

Item-context association rate

3 months

ID	Title	Description
OG000	Rapid Rehydration Using 0.45% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.

Secondary

Intelligence Quotient (IQ) Testing

IQ was assessed with the WASI (6-18 year olds) or WPPSI-III (3-5 year olds) at the 3 month follow-up visit. The Wechsler Abbreviated Scale of Intelligence (WASI) is a measure of IQ designed for individuals aged 6 to 89. The WASI includes four subtests; the Block Design and Matrix Reasoning tests measure Performance IQ, and the Vocabulary and Similarities tests measure Verbal IQ. Full scale IQ was computed from these scores and used for analyses. Scores typically vary from 75 to 135 with higher scores representing a better outcome.

All randomized subjects aged 3 years and older with 3-month follow-up and successful completion of IQ testing.

Posted

Mean

Standard Deviation

IQ points

3 months

ID	Title	Description
OG000	Rapid Rehydration Using 0.45% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
OG001	Rapid Rehydration Using 0.9% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Coagulopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG0030 events0 affected347 at risk
Lymphadenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Bradycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0022 events2 affected338 at risk EG003
Nodal Rythm	Cardiac disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0012 events2 affected344 at risk EG0023 events3 affected338 at risk EG003
Ventricular Extrasystoles	Cardiac disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0002 events2 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Middle ear effusion	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Eye irritation	Eye disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Eye pain	Eye disorders	Systematic Assessment	EG0002 events2 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Ocular hyperaemia	Eye disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Vision blurred	Eye disorders	Systematic Assessment	EG0003 events2 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected342 at risk EG00111 events11 affected344 at risk EG0027 events7 affected338 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0014 events4 affected344 at risk EG0022 events2 affected338 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0021 events1 affected338 at risk EG003
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0011 events1 affected344 at risk EG0021 events1 affected338 at risk EG003
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Gastrointestinal sounds abnormal	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Gingival pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Glossodynia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Haematemesis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Mouth ulceration	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0005 events5 affected342 at risk EG0013 events3 affected344 at risk EG0022 events2 affected338 at risk EG003
Oesophageal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Oesophagitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Oral Pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0023 events3 affected338 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Proctalgia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected342 at risk EG0014 events4 affected344 at risk EG0022 events2 affected338 at risk EG003
Catheter site inflammation	General disorders	Systematic Assessment	EG0002 events2 affected342 at risk EG0012 events2 affected344 at risk EG0020 events0 affected338 at risk EG003
Catheter site pain	General disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0010 events0 affected344 at risk EG0022 events2 affected338 at risk EG003
Chest discomfort	General disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0012 events2 affected344 at risk EG0024 events4 affected338 at risk EG003
Chills	General disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0021 events1 affected338 at risk EG003
Complication associated with device	General disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Crying	General disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Facial pain	General disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Hypothermia	General disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Infusion site extravasation	General disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0021 events1 affected338 at risk EG003
Infusion site pain	General disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Injection site pain	General disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0022 events2 affected338 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Pain	General disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0022 events2 affected338 at risk EG003
Peripheral swelling	General disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0008 events8 affected342 at risk EG00111 events11 affected344 at risk EG0028 events8 affected338 at risk EG003
Abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Bacteraemia	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Candida infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Candiduria	Infections and infestations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Clostridium difficile colitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Fungal infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0021 events1 affected338 at risk EG003
Lice infestation	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Metapneumovirus infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0012 events2 affected344 at risk EG0020 events0 affected338 at risk EG003
Otitits media	Infections and infestations	Systematic Assessment	EG0002 events2 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Periorbital cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Pharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0012 events2 affected344 at risk EG0021 events1 affected338 at risk EG003
Pharyngitis streptococcal	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0012 events2 affected344 at risk EG0020 events0 affected338 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Pyuria	Infections and infestations	Systematic Assessment	EG0002 events2 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Skin candida	Infections and infestations	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Tooth infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Urethritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0023 events3 affected338 at risk EG003
Vaginal infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0012 events2 affected344 at risk EG0020 events0 affected338 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	Systematic Assessment	EG0002 events2 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Vuvlovaginitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Heart injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Medication error	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Amylase increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood bicarbonate decreased	Investigations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Blood chloride increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood creatinine phosphokinase decreased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood glucose decreased	Investigations	Systematic Assessment	EG0001 events1 affected342 at risk EG0013 events3 affected344 at risk EG0022 events2 affected338 at risk EG003
Blood glucose increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood immunoglobulin A increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood ketone body increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Blood magnesium decreased	Investigations	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood osmolarity decreased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Blood phosphorus decreased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood potassium decreased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0013 events3 affected344 at risk EG0021 events1 affected338 at risk EG003
Blood potassium increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood pressure increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood sodium decreased	Investigations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0022 events2 affected338 at risk EG003
Blood sodium increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Blood urea decreased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Cardiac murmur	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Coma scale abnormal	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0014 events4 affected344 at risk EG0022 events1 affected338 at risk EG003
Crystal urine present	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Electrocardiogram QT prolonged	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Electrocardiogram T wave peaked	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Influenza A virus test positive	Investigations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Lipase increased	Investigations	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Liver function test increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Streptococcus test positive	Investigations	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Urinary casts	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Urine analysis abnormal	Investigations	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Urine output decreased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
White blood cell count increased	Investigations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected342 at risk EG0010 events0 affected344 at risk EG0023 events3 affected338 at risk EG003
Acidosis hyperchloraemic	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG00116 events16 affected344 at risk EG0024 events4 affected338 at risk EG003
Alkalosis	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Hyperchloraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0012 events2 affected344 at risk EG0020 events0 affected338 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0013 events3 affected344 at risk EG0020 events0 affected338 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0008 events8 affected342 at risk EG0014 events4 affected344 at risk EG0024 events4 affected338 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0012 events2 affected344 at risk EG0020 events0 affected338 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG00010 events10 affected342 at risk EG00110 events9 affected344 at risk EG00213 events12 affected338 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0009 events8 affected342 at risk EG00115 events15 affected344 at risk EG0028 events8 affected338 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events4 affected342 at risk EG0010 events0 affected344 at risk EG0025 events5 affected338 at risk EG003
Hypophagia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0015 events5 affected344 at risk EG0022 events2 affected338 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0012 events2 affected344 at risk EG0020 events0 affected338 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0012 events2 affected344 at risk EG0021 events1 affected338 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected342 at risk EG0013 events3 affected344 at risk EG0021 events1 affected338 at risk EG003
Trismus	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Brain oedema	Nervous system disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0011 events1 affected344 at risk EG0021 events1 affected338 at risk EG003
Dysarthria	Nervous system disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG00029 events29 affected342 at risk EG00116 events16 affected344 at risk EG00223 events23 affected338 at risk EG003
Seizure	Nervous system disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Syncope	Nervous system disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Agitation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Confusional state	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Irritability	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0012 events1 affected344 at risk EG0021 events1 affected338 at risk EG003
Mental status changes	Psychiatric disorders	Systematic Assessment	EG0005 events5 affected342 at risk EG0015 events5 affected344 at risk EG0024 events4 affected338 at risk EG003
Suicidal ideation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Incontinence	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Vulvovaginal pruritis	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0011 events1 affected344 at risk EG0022 events2 affected338 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0022 events2 affected338 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0009 events9 affected342 at risk EG00111 events11 affected344 at risk EG00210 events10 affected338 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Stridor	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Pruritis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0011 events1 affected344 at risk EG0021 events1 affected338 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected342 at risk EG0011 events1 affected344 at risk EG0024 events4 affected338 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Skin warm	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Flushing	Vascular disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0004 events4 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0012 events2 affected344 at risk EG0022 events2 affected338 at risk EG003
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Peripheral coldness	Vascular disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Phlebitis	Vascular disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Poor peripheral circulation	Vascular disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D007662	Ketosis
D000138	Acidosis
D000137	Acid-Base Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rapid Rehydration Using 0.45% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.	1	342	5	342	112	342
EG001	Rapid Rehydration Using 0.9% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.	0	344	4	344	124	344
EG002	Slower Rehydration Using 0.45% Saline Replacement Fluid	This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.	0	338	11	338	117	338
EG003	Slower Rehydration Using 0.9% Saline Replacement Fluid	This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.	0	347	10	347	129	347

Term	Organ System	Assessment Type	Statistical Information
Cardiac Arrest	Cardiac disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG0030 events0 affected347 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Hepatomegaly	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Brain oedema	Nervous system disorders	Systematic Assessment	EG0002 events2 affected342 at risk EG0012 events2 affected344 at risk EG0028 events8 affected338 at risk EG003
Renal injury	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Hypovolemic shock	Vascular disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0021 events1 affected338 at risk EG003
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0011 events1 affected344 at risk EG0020 events0 affected338 at risk EG003
Acidosis hyperchloraemic	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Somnolence	Nervous system disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected342 at risk EG0010 events0 affected344 at risk EG0020 events0 affected338 at risk EG003