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

NCT ID: NCT01909336

Last Updated: 2016-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-04-30

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.

Conditions

Hyponatremia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: 0.3% Saline in 3.3% dextrose (intravenous)

Group 1: 0.3% Saline in 3.3% dextrose (intravenous)

Group Type: ACTIVE_COMPARATOR

0.3% Saline in 3.3% dextrose

Intervention Type: DRUG

Hypotonic Solutions: 0.3% Saline in 3.3% dextrose

Group 2: 0.45% Saline in 5% dextrose (intravenous)

Group 2: 0.45% Saline in 5% dextrose (intravenous)

Group Type: ACTIVE_COMPARATOR

0.45% Saline in 5% dextrose

Intervention Type: DRUG

Hypotonic Solutions: 0.45% Saline in 5% dextrose

Group 3: 0.9% Saline in 5% dextrose (intravenous)

Group 3: 0.9% Saline in 5% dextrose (intravenous)

Group Type: ACTIVE_COMPARATOR

0.9% Saline in 5% dextrose

Intervention Type: DRUG

Isotonic Solutions 0.9% Saline in 5% dextrose

Interventions

0.3% Saline in 3.3% dextrose

Hypotonic Solutions: 0.3% Saline in 3.3% dextrose

Intervention Type: DRUG

0.45% Saline in 5% dextrose

Hypotonic Solutions: 0.45% Saline in 5% dextrose

Intervention Type: DRUG

0.9% Saline in 5% dextrose

Isotonic Solutions 0.9% Saline in 5% dextrose

Intervention Type: DRUG

Other Intervention Names

Hypotonic Solutions: 0.3% Saline + 3.3% dextrose; Hypotonic Solutions: 0.45% Saline in 5% dextrose; Isotonic Solutions 0.9% Saline in 5% dextrose

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tecnologico de Monterrey

OTHER

Sponsor Role: collaborator

Instituto Tecnologico y de Estudios Superiores de Monterey

OTHER

Sponsor Role: lead

Responsible Party

Claudia Montserrat Flores Robles, MD

Claudia Montserrat Flores Robles

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Montserrat Flores Robles, MD

Role: PRINCIPAL_INVESTIGATOR

Tecnologico de Monterrey

Carlos Alberto Cuello García, MD

Role: STUDY_DIRECTOR

Centro de Medicina Basada en Evidencias, Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey.

References

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.

Reference Type: BACKGROUND

PMID: 17592470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16754657 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18838929 (View on PubMed)

Other Identifiers

SIvsSHnh

Identifier Type: -

Identifier Source: org_study_id