Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT02046135|
Recruitment Status : Terminated (Statistical analysis at interim analysis determined futility in continuing.)
First Posted : January 27, 2014
Results First Posted : December 28, 2020
Last Update Posted : December 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury Congenital Heart Disease||Drug: Sodium Bicarbonate Drug: Sodium Chloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery: A Randomized Clinical Trial|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||July 22, 2017|
Experimental: 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.
Drug: Sodium Bicarbonate
Active Comparator: 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.
Drug: Sodium Chloride
- Acute Kidney Injury [ Time Frame: 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.
- Cumulative Fluid Balance [ Time Frame: 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.
- Hospital and Intensive Care Unit Length of Stay [ Time Frame: 1 month ]Hospital and intensive care unit length of stay in days
- Need for Dialysis [ Time Frame: 1 month ]Need for dialysis: yes/no
- Length of Mechanical Ventilation [ Time Frame: 1 month ]Length of mechanical ventilation in days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046135
|United States, New York|
|Cohen Children's Medical Center of New York|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||James Schneider, MD||Cohen Children's Medical Center of New York|