Phase 3
N=161
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
Hyponatremia
Bottom Line
View on ClinicalTrials.gov: NCT01909336 ↗Enrolled (actual)
161
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Hospital Acquired Hyponatremia — 10; 11; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 0.3% Saline in 3.3% dextrose (Drug); 0.45% Saline in 5% dextrose (Drug); 0.9% Saline in 5% dextrose (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Acquired Hyponatremia |
10; 11; 1 | — |
| SECONDARY Dysnatraemias at T8 |
26; 30; 47; 23; 20; 3 | — |
| SECONDARY Adverse Reactions Attributed to Acute Plasma Sodium Changes |
12; 13; 11 | — |
Summary
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.
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 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
Data sourced from ClinicalTrials.gov (NCT01909336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.