MedTrace Logo

Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol

NCT01120964 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-07-27

Study results available
· View outcomes & findings →

Summary

This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery. Participants will be randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in it).

Citrulline is a protein building block in the body that can convert into another substance, nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in the lungs can be an important surgical problem; it may also lead to problems following surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The hypothesis of this study is that perioperative supplementation with intravenous citrulline will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical ventilation.

The objective of this study is to determine in a randomized placebo controlled phase IB multicenter clinical trial if a revised protocol of intravenous L-citrulline delivery given perioperatively achieves a plasma citrulline level of \> 100 umol/L in children undergoing surgical repair of an atrial septal defect,ventricular septal defect or an atrioventricular septal defect.

Conditions

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

Interventions

DRUG

Intravenous L-Citrulline

DRUG

Placebo of Intravenous L-Citrulline

Placebo of intravenous L-Citrulline given at the same prescribed times as L-Citrullne Drug

Sponsors & Collaborators

  • Asklepion Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Frederick E Barr, MD · Batson Children's Hospital, University of Mississippi Medical Center

  • Catherine Krawczeski, MD · Children's Hospital Medical Center, Cincinnati

  • Allan Doctor, MD · St. Louis Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01120964 on ClinicalTrials.gov