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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 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Ventricular Septal Defect
  • Atrioventricular Septal Defect
  • Primum Atrial Septal Defect

Interventions

DRUG

L-citrulline

Intravenous L-citrulline given for up to 48 hours

DRUG

Plasmalyte A

Intravenous Plasmalyte A given for up to 48 hours

Sponsors & Collaborators

  • Asklepion Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Christopher Mastropietro, MD, FCCM · Riley Hospital for Children at Indiana University Health

  • Gurdyal Kalsi, MD, MFPM · Asklepion Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2024-05-10
Completion
2024-05-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05253209 on ClinicalTrials.gov