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

NCT01909336 | Completed Phase 3 Results DMC

• 1 other identifier: SIvsSHnh
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hyponatremia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dysnatraemias at T8

  8 hours

• Adverse Reactions Attributed to Acute Plasma Sodium Changes

  8 hours

Study Arms (3)

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

ACTIVE COMPARATOR

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

Drug: 0.3% Saline in 3.3% dextrose

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

ACTIVE COMPARATOR

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

Drug: 0.45% Saline in 5% dextrose

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

ACTIVE COMPARATOR

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

Drug: 0.9% Saline in 5% dextrose

Interventions

0.3% Saline in 3.3% dextrose DRUG

Hypotonic Solutions: 0.3% Saline in 3.3% dextrose

Also known as: Hypotonic Solutions: 0.3% Saline + 3.3% dextrose

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

0.45% Saline in 5% dextrose DRUG

Hypotonic Solutions: 0.45% Saline in 5% dextrose

Also known as: Hypotonic Solutions: 0.45% Saline in 5% dextrose

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

0.9% Saline in 5% dextrose DRUG

Isotonic Solutions 0.9% Saline in 5% dextrose

Also known as: Isotonic Solutions 0.9% Saline in 5% dextrose

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

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Tecnologico y de Estudios Superiores de Monterey: lead
• Tecnologico de Monterrey: collaborator

Related Publications (3)

• 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.

  PMID: 17592470 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.

  PMID: 16754657 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.

  PMID: 18838929 BACKGROUND

MeSH Terms

Conditions

Hyponatremia

Interventions

Sodium Chloride; Glucose; Hypotonic Solutions; Isotonic Solutions

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Claudia Montserrat Flores Robles
• Organization: HIMFG

montseflores@hotmail.com

(52) 5566756686

Study Officials

• Claudia Montserrat Flores Robles, MD

  Tecnologico de Monterrey

  PRINCIPAL INVESTIGATOR

• Carlos Alberto Cuello García, MD

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Claudia Montserrat Flores Robles

Study Record Dates

• First Submitted: July 14, 2013
• First Posted: July 26, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 16, 2016
• Results First Posted: December 16, 2016

Record last verified: 2016-10