drugset / Trial / NCT02046135

Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery

NCT02046135

Phase 2 Terminated 51 enrolled Northwell Health
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bicarbonate in the perioperative period when compared to placebo. The specific aims of this proposal are as follows: 1\. To institute a prospective, randomized, double-blinded, placebo-controlled trial in pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.

Timeline

Start
2013-09
Primary completion
2017-06
Completion
2017-07-22

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium bicarbonate Diagnostic / imaging agent Intravenous
Comparator sodium chloride Unknown Intravenous