Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia

Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia.

The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.

Study Overview

• Status: Completed
• Conditions: Hyponatremia
• Intervention / Treatment: Drug: 0.3% Saline in 3.3% dextrose; Drug: 0.45% Saline in 5% dextrose; Drug: 0.9% Saline in 5% dextrose

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.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: 0.3% Saline in 3.3% dextrose (intravenous)	Drug: 0.3% Saline in 3.3% dextrose; Hypotonic Solutions: 0.3% Saline in 3.3% dextrose; Other Names: Hypotonic Solutions: 0.3% Saline + 3.3% dextrose
Active Comparator: Group 2: 0.45% Saline in 5% dextrose (intravenous)	Drug: 0.45% Saline in 5% dextrose; Hypotonic Solutions: 0.45% Saline in 5% dextrose; Other Names: Hypotonic Solutions: 0.45% Saline in 5% dextrose
Active Comparator: Group 3: 0.9% Saline in 5% dextrose (intravenous)	Drug: 0.9% Saline in 5% dextrose; Isotonic Solutions 0.9% Saline in 5% dextrose; Other Names: Isotonic Solutions 0.9% Saline in 5% dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours	8 hours

Collaborators and Investigators

• Sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
• Collaborators: Tecnologico de Monterrey
• Investigators: Principal Investigator: Claudia Montserrat Flores Robles, MD, Tecnologico de Monterrey; Study Director: Carlos Alberto Cuello García, MD, Centro de Medicina Basada en Evidencias, Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: July 14, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia; Pharmaceutical Solutions
• Other Study ID Numbers: SIvsSHnh