drugset / Trial / NCT00621348

Maintenance Intravenous Fluids in Children

NCT00621348 ↗

Phase 3 Completed 167 enrolled All India Institute of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-09
Primary completion
2008-04
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hypotonic fluid Unknown — Intravenous
Comparator Isotonic fluid Unknown — Intravenous

Indications

No indication recorded.