Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
Primary Purpose
Hyponatremia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
0.3% Saline in 3.3% dextrose
0.45% Saline in 5% dextrose
0.9% Saline in 5% dextrose
Sponsored by
About this trial
This is an interventional treatment trial for Hyponatremia
Eligibility Criteria
Inclusion Criteria:
- Children between 3 months to 15 years.
- Need for intravenous fluids for 8 hours or more.
- Normal serum sodium at the beginning of the study of the study (135-145 mEQ/L).
- Acute respiratory problems (acute asthma attack, bronchiolitis or pneumonia).
- Acute gastrointestinal disorders (viral o bacterial gastroenteritis).
- Elective surgical procedures.
- Pre, peri o post operative patients (acute appendicitis, intussusception, intestinal perforation, ileus).
Exclusion Criteria:
- Severe hyponatremia (serum sodium < 125 mEq/L).
- Severe hypernatremia (serum sodium >155 mEq/L).
- Need for intravenous fluids for less than 8 hours according with their treating physician.
- Severe dehydration or Shock.
- Preexisting chronic diseases (renal diseases, heart diseases or endocrine disorders).
- Neurologic diseases.
- Head trauma.
- Cerebral edema or Intracranial hypertension.
- Diabetic ketoacidosis.
- Use of diuretics one week or less before the study.
- Need for admission to the pediatric critical intensive care unit
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1: 0.3% Saline in 3.3% dextrose (intravenous)
Group 2: 0.45% Saline in 5% dextrose (intravenous)
Group 3: 0.9% Saline in 5% dextrose (intravenous)
Arm Description
Group 1: 0.3% Saline in 3.3% dextrose (intravenous)
Group 2: 0.45% Saline in 5% dextrose (intravenous)
Group 3: 0.9% Saline in 5% dextrose (intravenous)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Adverse Reactions Attributed to Acute Plasma Sodium Changes
Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours
Full Information
NCT ID
NCT01909336
First Posted
July 14, 2013
Last Updated
October 21, 2016
Sponsor
Instituto Tecnologico y de Estudios Superiores de Monterey
Collaborators
Tecnologico de Monterrey
1. Study Identification
Unique Protocol Identification Number
NCT01909336
Brief Title
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
Official Title
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Tecnologico y de Estudios Superiores de Monterey
Collaborators
Tecnologico de Monterrey
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: 0.3% Saline in 3.3% dextrose (intravenous)
Arm Type
Active Comparator
Arm Description
Group 1: 0.3% Saline in 3.3% dextrose (intravenous)
Arm Title
Group 2: 0.45% Saline in 5% dextrose (intravenous)
Arm Type
Active Comparator
Arm Description
Group 2: 0.45% Saline in 5% dextrose (intravenous)
Arm Title
Group 3: 0.9% Saline in 5% dextrose (intravenous)
Arm Type
Active Comparator
Arm Description
Group 3: 0.9% Saline in 5% dextrose (intravenous)
Intervention Type
Drug
Intervention Name(s)
0.3% Saline in 3.3% dextrose
Other Intervention Name(s)
Hypotonic Solutions: 0.3% Saline + 3.3% dextrose
Intervention Description
Hypotonic Solutions: 0.3% Saline in 3.3% dextrose
Intervention Type
Drug
Intervention Name(s)
0.45% Saline in 5% dextrose
Other Intervention Name(s)
Hypotonic Solutions: 0.45% Saline in 5% dextrose
Intervention Description
Hypotonic Solutions: 0.45% Saline in 5% dextrose
Intervention Type
Drug
Intervention Name(s)
0.9% Saline in 5% dextrose
Other Intervention Name(s)
Isotonic Solutions 0.9% Saline in 5% dextrose
Intervention Description
Isotonic Solutions 0.9% Saline in 5% dextrose
Primary Outcome Measure Information:
Title
Hospital Acquired Hyponatremia
Description
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
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Dysnatraemias at T8
Description
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)
Time Frame
8 hours
Title
Adverse Reactions Attributed to Acute Plasma Sodium Changes
Description
Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children between 3 months to 15 years.
Need for intravenous fluids for 8 hours or more.
Normal serum sodium at the beginning of the study of the study (135-145 mEQ/L).
Acute respiratory problems (acute asthma attack, bronchiolitis or pneumonia).
Acute gastrointestinal disorders (viral o bacterial gastroenteritis).
Elective surgical procedures.
Pre, peri o post operative patients (acute appendicitis, intussusception, intestinal perforation, ileus).
Exclusion Criteria:
Severe hyponatremia (serum sodium < 125 mEq/L).
Severe hypernatremia (serum sodium >155 mEq/L).
Need for intravenous fluids for less than 8 hours according with their treating physician.
Severe dehydration or Shock.
Preexisting chronic diseases (renal diseases, heart diseases or endocrine disorders).
Neurologic diseases.
Head trauma.
Cerebral edema or Intracranial hypertension.
Diabetic ketoacidosis.
Use of diuretics one week or less before the study.
Need for admission to the pediatric critical intensive care unit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Montserrat Flores Robles, MD
Organizational Affiliation
Tecnologico de Monterrey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Alberto Cuello García, MD
Organizational Affiliation
Centro de Medicina Basada en Evidencias, Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17592470
Citation
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.
Results Reference
background
PubMed Identifier
16754657
Citation
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.
Results Reference
background
PubMed Identifier
18838929
Citation
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.
Results Reference
background
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Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
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