drugset / Trial / NCT05253209

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

NCT05253209

Phase 3 Terminated 64 enrolled Asklepion Pharmaceuticals, LLC
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2022-06-29
Primary completion
2024-05-10
Completion
2024-05-10

Drugs

EvaluationDrugModalityDoseRoute
Subject L-citrulline Other / unclassified 9 mg/kg Intravenous