- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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New Hyde Park, New York, United States, 11040
- Cohen Children's Medical Center of New York
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Kidney Injury
Time Frame: 7 days
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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.
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Fluid Balance
Time Frame: 6 days
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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.
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6 days
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Hospital and Intensive Care Unit Length of Stay
Time Frame: 1 month
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Hospital and intensive care unit length of stay in days
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1 month
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Need for Dialysis
Time Frame: 1 month
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Need for dialysis: yes/no
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1 month
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Length of Mechanical Ventilation
Time Frame: 1 month
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Length of mechanical ventilation in days
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Schneider, MD, Cohen Children's Medical Center of New York
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-007B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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