Phase 3
N=167
Maintenance Intravenous Fluids in Children
Hyponatremia
Bottom Line
View on ClinicalTrials.gov: NCT00621348 ↗Enrolled (actual)
167
Serious AEs
1.2%
Results posted
Aug 2011
Primary outcome: Primary: Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L) — 1; 2; 8 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Isotonic fluid (Drug); Hypotonic fluid (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- All India Institute of Medical Sciences
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L) |
1; 2; 8 | <0.05 sig |
| SECONDARY Incidence of Hypernatremia (Serum Sodium >150 mmol/L) |
2; 4; 2 | — |
| SECONDARY Incidence of Symptomatic Hyponatremia |
0; 1; 0 | — |
| SECONDARY Incidence of Symptomatic Hypernatremia |
0; 0; 0 | — |
Summary
Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children.
Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5% dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children receiving intravenous maintenance fluids.
Eligibility Criteria
Inclusion Criteria
- All children (3 months to 12 years) who are admitted to pediatric ward or pediatric ICU, who require exclusive intravenous maintenance fluid therapy for at least 24 hours will be eligible for the study
Exclusion Criteria
- Children with illness that have primary fluid and electrolyte imbalance such as:
- Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia ( 3 seconds), hypotension (BP 150 mmol/L.
- Hyperglycemia: blood glucose > 180 mg/ dl.
- Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
- Child who is receiving drugs which cause abnormality in serum sodium such as diuretics, vasopressin, etc.
Data sourced from ClinicalTrials.gov (NCT00621348). 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.