Clinical trialNCT05253209TerminatedPhase 3Interventional

A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects

SponsorAsklepion Pharmaceuticals, LLCEnrollment64Atrioventricular Septal DefectPrimum Atrial Septal DefectVentricular Septal Defect

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Christopher Mastropietro, MD, FCCM
Riley Hospital for Children at Indiana University Health
Principal Investigator
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Gurdyal Kalsi, MD, MFPM
Asklepion Pharmaceuticals, LLC
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S of Alabama
Birmingham, Alabama, United States
Children'S Hospital of Colorado
Aurora, Colorado, United States
Heart Center, Ann & Robert H. Lurie Children'S Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Cardinal Glennon Children'S Hospital
St Louis, Missouri, United States
Duke University Medical Center Surgical Office of Clinical Research (socr)
Durham, North Carolina, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children'S Hospital- the Heart Center
Columbus, Ohio, United States
Seattle Children'S Research Institute
Seattle, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CitrullinePlasmalyte A

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Jun 2022
Primary completion: 10 May 2024
Completion: 10 May 2024
Last update posted: 19 Sept 2024
Registered enrollment: 64
Registry id: NCT05253209

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.