Overview

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

Status:
Terminated
Trial end date:
2017-07-22
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwell Health
Criteria
Inclusion Criteria:

1. Subjects age ≤18 years

2. Subjects scheduled for cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the
Schwartz formula

2. Subjects with known cystic kidney disease or posterior ureteral valves (subjects with
solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be
excluded if renal function is preserved)

3. Subjects with known metabolic disorder

4. Premature infants born <30 weeks gestation and <30 days old due to risk of
intraventricular hemorrhage

Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane
oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the
study.