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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
James Schneider, 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Congenital Heart Disease Drug: Sodium Bicarbonate Drug: Sodium Chloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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.
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Hospital and Intensive Care Unit Length of Stay [ Time Frame: 1 month ]
    Hospital and intensive care unit length of stay in days

  3. Need for Dialysis [ Time Frame: 1 month ]
    Need for dialysis: yes/no

  4. Length of Mechanical Ventilation [ Time Frame: 1 month ]
    Length of mechanical ventilation in days

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02046135

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United States, New York
Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
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Principal Investigator: James Schneider, MD Cohen Children's Medical Center of New York
  Study Documents (Full-Text)

Documents provided by James Schneider, Northwell Health:
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Responsible Party: James Schneider, Fellowship Director Critical Care, Northwell Health Identifier: NCT02046135    
Other Study ID Numbers: 13-007B
First Posted: January 27, 2014    Key Record Dates
Results First Posted: December 28, 2020
Last Update Posted: December 28, 2020
Last Verified: December 2020
Keywords provided by James Schneider, Northwell Health:
Sodium bicarbonate
Acute kidney injury
Cardiac surgery
Additional relevant MeSH terms:
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Acute Kidney Injury
Heart Diseases
Heart Defects, Congenital
Wounds and Injuries
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cardiovascular Abnormalities
Congenital Abnormalities