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



Status:Recruiting
Conditions:Hospital, Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:Any - 18
Updated:3/28/2019
Start Date:August 2016
End Date:October 2019
Contact:Cindy Zychowicz, BA
Email:Cindy.zychowicz@asklepionpharm.com
Phone:410-545-0494

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A Phase III Double-Blind, Randomized, Placebo Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Subjects Undergoing Surgery for Congenital Heart Defects

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.

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 μmol/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 μmol/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.

Inclusion Criteria:

- Subjects, parents, or legal guardian of the subject who are willing and able to sign
informed consent

- Male and female subjects aged ≤18 years of age

- Infants, children and adolescents undergoing CPB for repair of a large unrestrictive
VSD, an ostium primum ASD, or a partial or complete AVSD

- Pre-operative echocardiogram which confirms the cardiovascular anatomy and defect to
be surgically repaired

Exclusion Criteria:

- Evidence of pulmonary artery or vein abnormalities on the pre-operative echocardiogram
that will not be addressed surgically. Specific abnormalities excluded include the
following:

- Significant pulmonary artery narrowing not amenable to surgical correction

- Previous pulmonary artery stent placement

- Significant left sided AV valve regurgitation not amenable to surgical correction

- Pulmonary venous return abnormalities not amenable to surgical correction

- Pulmonary vein stenosis not amenable to surgical correction

- Preoperative requirement for mechanical ventilation or intravenous inotrope support

- Presence of fixed or idiopathic pulmonary hypertension (i.e. Eisenmenger's Syndrome)
prior to surgical repair

- Pre-operative use of medications to treat pulmonary hypertension

- Pregnancy; Females of child-bearing potential must be willing to participate an
acceptable method of birth control for the duration of study participation (e.g. oral
contraceptive, hormonal implant, intra-uterine device)

- Any condition which, in the opinion of the investigator, might interfere with the
study objectives

- Participation in another clinical trial within 30 days of Screening or while
participating in the current study, including the 28 days of follow-up post study drug
administration
We found this trial at
21
sites
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Janet Simsic, MD
Phone: 614-355-5763
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: David Cooper, MD
Phone: 513-636-0170
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Mary B Taylor, MD
Phone: 601-984-4409
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Carly Scahill, DO
Phone: 720-777-8654
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Narutoshi Hibino, MD
Phone: 667-208-7083
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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Birmingham, Alabama 35294
Principal Investigator: Santiago Borasino, MD
Phone: 205-996-3313
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Birmingham, AL
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Bronx, New York 10467
Principal Investigator: Giles Peek, MD
Phone: 718-920-4539
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Bronx, NY
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Graz,
Principal Investigator: Gernot Grangl, MD
Phone: +43 316 385 78025
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Indianapolis, Indiana 46202
Principal Investigator: Christopher Mastropietro, MD
Phone: 317-944-3346
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Indianapolis, IN
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Loma Linda, California 92354
Principal Investigator: Richard Lion, DO
Phone: 909-558-5830
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Loma Linda, CA
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Petros V Anagnostopoulos, MD
Phone: 608-262-1551
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Miami, Florida 33155
Principal Investigator: Jun Sasaki, MD
Phone: 786-624-2425
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Emile Bacha, MD
Phone: 212-342-2104
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oak Lawn, Illinois 60453
Principal Investigator: Andrew Van Bergen, MD
Phone: 708-684-3772
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Orlando, Florida 32806
Principal Investigator: Sukumar Narasimhulu, MD
Phone: 321-841-7485
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Gary Raff, MD
Phone: 916-453-5085
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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1465 South Grand Boulevard
Saint Louis, Missouri 63104
Principal Investigator: Jason Werner, MD
Phone: 573-625-1949
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1 Childrens Place
Saint Louis, Missouri 63110
Principal Investigator: Pirooz Eghtesady, MD
Phone: 314-362-1729
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Salt Lake City, Utah 84143
Principal Investigator: Kristi A Glotzbach, MD
Phone: 801-587-7523
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Monique Radman, MD
Phone: 206-987-1336
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Nina Deutsch, MD
Phone: 202-476-4882
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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