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| Name | Class |
|---|---|
| Tecnologico de Monterrey | OTHER |
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The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.
Multicenter, Randomized, Controlled clinical trial.
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions
This study will include 150 patients in 2 groups according to these type of pathology: group 1: medical conditions which includes respiratory problems (pneumonia, bronchiolitis, acute asthma attack) and acute gastrointestinal problems (bacterial or viral gastroenteritis) and group 2: surgical conditions (pre, peri or postoperative patients will be included). Each group will be randomized to receive 3 types of interventions: 0.3% Saline (hypotonic solution), 0.45% Saline (hypotonic solution) or 0.9% Saline (isotonic solution). In non-dehydrated patients the daily total volume of liquid infused will be determined by the volumetric Holliday- Segar* formula and the daily total volume will be calculated by adding the maintenance requirements (using the Holliday Segar formula) to the fluid deficit (according to percent of estimated weight**) in dehydrated patients.
The glucose concentrations in the first group will be 3.3%, and in group 2 and 3 will be 5%. The potassium concentration will be 20mEq/L in all groups. Blood samples will be collected before, 8 hours and 24 hours after the start of intravenous fluid, for the analysis of sodium, potassium, glucose, urea and creatinine. The adverse clinical outcomes at 8 and 24 hours of the start of intravenous fluid will also be recorded. The sodium plasma level, the incidence of hyponatremia and the adverse clinical outcomes will be compared.
*0-10 kilogram (kg): 100ml/kg per day; 10-20 kg: 1000 ml + 50 ml/kg/day over 10 kg; >20 kg: 1500 ml + 20ml/ kg over 20kg
** In patients under 10 kg correspond to a loss of 5% (50 mL/kg) in mild dehydration and 10% in moderate dehydration. In 10 kg or more: 3% (30 mL/kg) in mild dehydration and 6% (60 mL/kg) in moderate dehydration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 0.3% Saline in 3.3% dextrose (intravenous) | Active Comparator | Group 1: 0.3% Saline in 3.3% dextrose (intravenous) |
|
| Group 2: 0.45% Saline in 5% dextrose (intravenous) | Active Comparator | Group 2: 0.45% Saline in 5% dextrose (intravenous) |
|
| Group 3: 0.9% Saline in 5% dextrose (intravenous) | Active Comparator | Group 3: 0.9% Saline in 5% dextrose (intravenous) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3% Saline in 3.3% dextrose | Drug | Hypotonic Solutions: 0.3% Saline in 3.3% dextrose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Acquired Hyponatremia | Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Dysnatraemias at T8 | hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L) | 8 hours |
| Adverse Reactions Attributed to Acute Plasma Sodium Changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Montserrat Flores Robles, MD | Tecnologico de Monterrey | Principal Investigator |
| Carlos Alberto Cuello GarcÃa, MD | Centro de Medicina Basada en Evidencias, Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17592470 | Background | Moritz ML, Ayus JC. Hospital-acquired hyponatremia--why are hypotonic parenteral fluids still being used? Nat Clin Pract Nephrol. 2007 Jul;3(7):374-82. doi: 10.1038/ncpneph0526. | |
| 16754657 | Background | Choong K, Kho ME, Menon K, Bohn D. Hypotonic versus isotonic saline in hospitalised children: a systematic review. Arch Dis Child. 2006 Oct;91(10):828-35. doi: 10.1136/adc.2005.088690. Epub 2006 Jun 5. |
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This trial was conducted in the paediatric and emer- gency departments of the Hospital Regional Materno Infantil de Alta Especialidad in Nuevo Leon, Mexico between August 2013 and February 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous) | Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions |
| FG001 | Group 2: 0.45% Saline in 5% Dextrose (Intravenous) | Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions |
| FG002 | Group 3: 0.9% Saline in 5% Dextrose (Intravenous) | Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous) | Group 1: 0.3% Saline in 3.3% dextrose (intravenous) 0.3% Saline in 3.3% dextrose: Hypotonic Solutions: 0.3% Saline in 3.3% dextrose |
| BG001 | Group 2: 0.45% Saline in 5% Dextrose (Intravenous) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Hospital Acquired Hyponatremia | Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study | Posted | Number | participants | 8 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous) | Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia Montserrat Flores Robles | HIMFG | (52) 5566756686 | montseflores@hotmail.com |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D005947 | Glucose |
| D007038 | Hypotonic Solutions |
| D007552 | Isotonic Solutions |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.45% Saline in 5% dextrose | Drug | Hypotonic Solutions: 0.45% Saline in 5% dextrose |
|
|
| 0.9% Saline in 5% dextrose | Drug | Isotonic Solutions 0.9% Saline in 5% dextrose |
|
|
Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours |
| 8 hours |
| 18838929 | Background | Montanana PA, Modesto i Alapont V, Ocon AP, Lopez PO, Lopez Prats JL, Toledo Parreno JD. The use of isotonic fluid as maintenance therapy prevents iatrogenic hyponatremia in pediatrics: a randomized, controlled open study. Pediatr Crit Care Med. 2008 Nov;9(6):589-97. doi: 10.1097/PCC.0b013e31818d3192. |
Group 2: 0.45% Saline in 5% dextrose (intravenous) 0.45% Saline in 5% dextrose: Hypotonic Solutions: 0.45% Saline in 5% dextrose |
| BG002 | Group 3: 0.9% Saline in 5% Dextrose (Intravenous) | Group 3: 0.9% Saline in 5% dextrose (intravenous) 0.9% Saline in 5% dextrose: Isotonic Solutions 0.9% Saline in 5% dextrose |
| BG003 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Dehydration (mild), n | Dry mucous membranes in association with normal hemodynamic measurements | Number | participants |
|
| Systolic blood pressure, mmHg | Mean | Standard Deviation | mmHg |
|
| Heart rate, bpm | Mean | Standard Deviation | bpm |
|
| Serum sodium, mmol/L | Mean | Standard Deviation | mmol/L |
|
| Serum osmolarity, mOsm/L | Mean | Standard Deviation | mOsm/L |
|
| Normonatremic, n | defined as serum sodium 135-145 mmol/L | Number | participants |
|
| Hyponatraemia, n | defined as serum sodium < 135 mmol/L. | Number | participants |
|
| Hypernatremic, n | defined as serum sodium > 145 mmol/L. | Number | participants |
|
Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions |
|
|
| Secondary | Dysnatraemias at T8 | hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L) | Posted | Number | participants | 8 hours |
|
|
|
| Secondary | Adverse Reactions Attributed to Acute Plasma Sodium Changes | Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours | Posted | Number | Minor Adverse Reactions | 8 hours |
|
|
|
| 0 |
| 49 |
| 12 |
| 49 |
| EG001 | Group 2: 0.45% Saline in 5% Dextrose (Intravenous) | Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions | 0 | 50 | 13 | 50 |
| EG002 | Group 3: 0.9% Saline in 5% Dextrose (Intravenous) | Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions | 0 | 52 | 11 | 52 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Non-systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
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| D017670 |
| Sodium Compounds |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|---|
|
| Hypernatremia |
|