Last updated on October 2018

L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects

Brief description of study

The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.

Detailed Study Description

This is a randomized, double-blind, placebo controlled, multicenter study that will compare the efficacy and safety of L-citrulline versus placebo in subjects undergoing surgery for congenital heart defects.

Eligible subjects undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment in this study.

Each enrolled subject will be randomized to receive either L-citrulline or placebo throughout all administrations in the study. Subjects will receive an L-citrulline bolus of 150 mg/kg or placebo at the initiation of cardiopulmonary bypass, the addition of L-citrulline at a concentration of 200 mol/L or placebo given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations to compensate for fluids containing L-citrulline that may be removed from the patient during the course of the operation and thus to maintain the concentration of 200 mol/L. L-citrulline bolus of 20 mg/kg or placebo 30 minutes after decannulation from cardiopulmonary bypass, followed immediately by a 9 mg/kg/hr continuous L-citrulline infusion or placebo for up to 48 hours.

The study drug or placebo infusion will be discontinued once invasive arterial blood pressure monitoring is discontinued or at 48 hours, whichever comes first. Subjects will be followed until Day 28 or discharge from the hospital, whichever comes first. For subjects discharged prior to Day 28, a final assessment via telephone will be conducted at Day 28.

Clinical Study Identifier: NCT02891837

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Santiago Borasino, MD

University of Alabama
Birmingham, AL United States
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Gary Raff, MD

University of California Davis Medical Center
Sacramento, CA United States
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Carly Scahill, DO

Children's Hospital Colorado
Aurora, CO United States
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Jun Sasaki, MD

Nicklaus Children's Hospital
Miami, FL United States
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William DeCampli, MD

Arnold Palmer Hospital for Children
Orlando, FL United States
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Andrew Van Bergen, MD

Advocate Children's Hospital
Oak Lawn, IL United States
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Christopher Mastropietro, MD

Riley Hospital for Children at Indiana University
Indianapolis, IN United States
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Narutoshi Hibino, MD

The Johns Hopkins Hospital
Baltimore, MD United States
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Jason Werner, MD

St Louis University, SSM Health Cardinal Glennon Children's Hospital
Saint Louis, MO United States
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Pirooz Eghtesady, MD

Washington University School of Medicine/ St Louis Children's Hospital
Saint Louis, MO United States
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Emile Bacha, MD

Columbia University Medical Center
New York, NY United States
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David Cooper, MD

Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Janet Simsic, MD

Nationwide Children's Hospital
Columbus, OH United States
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Monique Radman, MD

Seattle Children's Hospital
Seattle, WA United States
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Assad Khoury, MD

Rambam Health Care Center
Haifa, Israel
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Nina Deutsch, MD

Children's National Medical Center
Washington, WA United States
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Giles Peek, MD

The Children's Hospital at Montefiore
Bronx, NY United States
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Petros V Anagnostopoulos, MD

University of Wisconsin
Madison, WI United States
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Mary B Taylor, MD

University of Mississippi Medical Center
Jackson, MS United States
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Kristi A Glotzbach, MD

Primary Children's Hospital
Salt Lake City, UT United States
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Asma Razavi, MD

Loma Linda University Children's Hospital
Loma Linda, CA United States
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