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

• ClinicalTrials.gov Identifier: NCT02046135
• Recruitment Status: Terminated
• First Posted: January 27, 2014
• Results First Posted: December 28, 2020
• Last Update Posted: December 28, 2020
• Sponsor: Northwell Health
• Information provided by (Responsible Party): James Schneider, Northwell Health

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: James Schneider, MD; Cohen Children's Medical Center of New York

  Study Documents (Full-Text)

Documents provided by James Schneider, Northwell Health:

Study Protocol and Statistical Analysis Plan  [PDF] June 15, 2013

More Information

• Responsible Party: James Schneider, Fellowship Director Critical Care, Northwell Health
• ClinicalTrials.gov Identifier: NCT02046135
• Other Study ID Numbers: 13-007B
• First Posted: January 27, 2014
• Results First Posted: December 28, 2020
• Last Update Posted: December 28, 2020
• Last Verified: December 2020

Keywords provided by James Schneider, Northwell Health:

Pediatric; Sodium bicarbonate; Acute kidney injury; Cardiac surgery

Additional relevant MeSH terms:

Acute Kidney Injury; Heart Diseases; Heart Defects, Congenital; Wounds and Injuries; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Cardiovascular Abnormalities; Congenital Abnormalities