189
Participants
Start Date
August 31, 2016
Primary Completion Date
June 30, 2019
Study Completion Date
July 31, 2019
L-citrulline
"* Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass, but after removal of any crystalloid base;~* Addition of study medication at a concentration of 200 μmol/L 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;~* Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass;~* 9 mg/kg/hr continuous infusion for up to 48 hours."
Placebo
"* Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass;~* Addition of placebo matched for volume given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations during bypass;~* Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass;~* 9 mg/kg/hr continuous infusion for up to 48 hours."
Medizinische Universität Wien, Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie Kinderherzzentrum, Vienna
LKH-Universitätsklinikum Graz Universitätsklinik für Kinder- und Jugendheilkunde, Graz
Columbia University Medical Center, New York
The Children's Hospital at Montefiore, The Bronx
Children's National Medical Center, Washington D.C.
The Johns Hopkins Hospital, Baltimore
Medizinische Hochschule Hannover, Hanover
Arnold Palmer Hospital for Children, Orlando
Nicklaus Children's Hospital, Miami
University of Alabama, Birmingham
Universitätsmedizin Göttingen, Göttingen
Nationwide Children's Hospital, Columbus
Cincinnati Children's Hospital Medical Center, Cincinnati
Riley Hospital for Children at Indiana University, Indianapolis
Advocate Children's Hospital, Oak Lawn
St Louis University, SSM Health Cardinal Glennon Children's Hospital, St Louis
Washington University School of Medicine/ St Louis Children's Hospital, St Louis
Children's Hospital Colorado, Aurora
Klinik für Kinderkardiologie und angeborene Herzfehler. Deutsches Herzzentrum München - Klinik an der TU München, München
Primary Children's Hospital, Salt Lake City
Loma Linda University Children's Hospital, Loma Linda
University of California Davis Medical Center, Sacramento
Seattle Children's Hospital, Seattle
Rambam Health Care Center, Haifa
Sheba Medical Center, Ramat Gan
Wolfson Medical Center, Holon
University of Mississippi Medical Center, Jackson
University of Wisconsin, Madison
Universitätsklinik Tübingen, Kinderkardiologie Pulmonologie, Intensivmedizin, Tübingen
Lead Sponsor
Asklepion Pharmaceuticals, LLC
INDUSTRY