Study Investigating the Use of Intravenous Fluids With De... | NCT01343758

Studies
Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children

NCT01343758

Sponsor

Boston Children's Hospital

Status

Completed

Last Update Posted

Feb 24, 2012Estimated

Enrollment

188Estimated

Phase

Not Applicable

Conditions

Gastroenteritis
Dehydration

Interventions

5% dextrose in normal saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Apr 27, 2011

First Submission Date that Met QC Criteria

Apr 27, 2011

First Posted Date

Apr 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2012

Last Update Posted Date

Feb 24, 2012Estimated

Name	Class
Abbott	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Infants and young children often become infected with gastroenteritis leading to vomiting and diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric Emergency Department. These children are often in need of treatment with intravenous (IV) fluids. While the investigators know that IV fluids work, it is not clear which type or how much fluid is the best amount to give. Currently, the most common type of IV fluid given is salt water, also called normal saline.

In contrast to adults, infants and young children with dehydration often have a build up of a certain type of acid in their blood which can perpetuate the nausea, vomiting, and general malaise associated with gastroenteritis. The investigators feel that giving these children IV fluids with lots of sugar (in addition to the salt) reduces the acid more rapidly than giving just salt water alone. In a prior study, the investigators have shown that children who receive lower amounts of sugar in the IV fluids return to the Emergency Department more often for a second visit. Based on this study, the investigators believe that children who receive the sugar-salt solution will do better than children who receive just normal saline.

The investigators will determine if the sugar-salt solution is better by giving equal numbers of children the sugar-salt solution and normal saline and then see what happens to each child. The investigators will monitor who needs to be admitted, how much each child vomits, how much each child drinks, and also the level of acid in the blood before and after getting the IV fluid. After the study is completed, the investigators can compare the two different groups (children who received the sugar-salt solution versus children who received normal saline alone) to determine if one group had greater improvement and better clinical outcome than the other.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

188Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5% dextrose in normal saline	Active Comparator	This group will receive a bolus of normal saline that contains 5% dextrose	Other: 5% dextrose in normal saline
Normal Saline Bolus	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5% dextrose in normal saline	Other	Subjects will be randomized to receive a intravenous fluid bolus of 5% dextrose in normal saline or normal saline	5% dextrose in normal saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Admission Rate	The investigators will measure what percentage of patients in each treatment group are admitted.	During emergency department visit

Secondary Outcomes

Measure	Description	Time Frame
Change in Serum Ketones	The investigators will measure the change in serum ketones at 1 and 2 hours after the study fluid is given and compare the mean change in each treatment group.	1 and 2 hours after treatment given

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6 months to 6 years of age
Gastroenteritis
Requires IV fluids for dehydration

Exclusion Criteria:

Chronic disease
Comorbid condition
Received IV fluids or antiemetics in the last 12 hours
Symptoms for more than 7 days
Blood glucose less than 40

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason A Levy, MD	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Boston		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D005759	Gastroenteritis
D003681	Dehydration

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose
D000077330	Saline Solution

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates
D000077324

Browse Leaves

Not provided

Browse Branches

Not provided