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

Phase 2

Terminated

Conditions: Acute Kidney Injury
Congenital Heart Disease

Interventions: Drug: Sodium Bicarbonate
Drug: Sodium Chloride

Registration Number: NCT02046135

Lead Sponsor: Northwell Health

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 51

Inclusion Criteria

Subjects age ≤18 years
Subjects scheduled for cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the Schwartz formula
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)
Subjects with known metabolic disorder
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post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium bicarbonate	Sodium Bicarbonate	At the start of the surgery, the patient will receive NaHCO3 as a continuous infusion of D5% 1/3NS + 100 meq/L NaHCO3 + 20 meq/L KCl at maintenance IVF (solution contains \~154 meq of sodium which is equivalent to normal saline). The NaHCO3 infusion will continue for the first 24 hours after the discontinuation of CPB. After 24 hours of receiving the NaHCO3 infusion, the IVF administered to the patient will be the standard solutions used in the PICU at CCMC.
Sodium Chloride	Sodium Chloride	At the start of surgery, patients in the control arm will receive D5% Normal Saline + 20 meq/L KCl at maintenance IVF. After 24 hours, standard IVF, not containing NaHCO3 or Na acetate will be administered for the duration of the PICU stay as required, determined by the clinicians primarily caring for the patient postoperatively.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	7 days	The number of patients who developed AKI in each arm of the study. AKI was measured by the Pediatric Risk, Failure, Loss of Function, and End-Stage Renal Disease (pRIFLE) criteria or an absolute increase in creatinine of 0.3mg/dl.

Secondary Outcome Measures

Name	Time	Method
Hospital and Intensive Care Unit Length of Stay	1 month	Hospital and intensive care unit length of stay in days
Cumulative Fluid Balance	6 days	Cumulative fluid balance in milliliters- comparison of all fluid intake vs all fluid output from the time of ICU admission post-operatively for the first 6 days post-operatively or until the time of discharge, whichever came first.
Length of Mechanical Ventilation	1 month	Length of mechanical ventilation in days
Need for Dialysis	1 month	Need for dialysis: yes/no