NCT02046135

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

Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery: A Randomized Clinical Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Kidney Injury
• Congenital Heart Disease

Interventions

Type	Name	Description
DRUG	Sodium Bicarbonate
DRUG	Sodium Chloride

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-06-01
• Completion: 2017-07-22
• First posted: 2014-01-27
• Last updated: 2022-11-02
• Results posted: 2020-12-28

Locations

1 site across 1 country: United States