NCT00201214

Brief Summary

This study will determine the pharmacokinetics and safety of intravenous citrulline given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 cardiovascular-diseases

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_1 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

2.1 years

First QC Date

September 16, 2005

Last Update Submit

September 10, 2013

Conditions

Cardiovascular DiseasesHeart DiseasesHeart Defects, Congenital

Outcome Measures

Primary Outcomes (3)

  • Oxygen index (OI) data to assess increased PVT

    Measured through the use of continuous mean arterial pressure monitoring

  • Qp:Qs ratios to assess increased PVT

    Measured by blood gases collected 48 hours post-operative

  • Increased PVT as measured by a sustained mean pulmonary artery pressure greater than 20 mm Hg for at least 2 hours during the first 24 hours postoperatively

    Measured through the use of continuous mean arterial pressure monitoring 48 hours post-operative

Interventions

CitrullineDRUG

Phase I - 150mg/kg IV bolus after initiation of cardiopulmonary bypass with dosage escalation study 50mg/kg, 100mg/kg, 150mg/kg IV at 6, 12, 24, 48 hours post operative. Phase II - 150mg/kg IV bolus after initiation of cardiopulmonary bypass with 9mg/kg/hr continuous IV starting 4 hours post bolus and infusing for 48 hours or discharge from PCCU.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Undergoing cardiopulmonary bypass via one of the following surgical procedures:
  • AVSD repair
  • VSD repair
  • Bidirectional Glenn
  • Modified Fontan
  • Arterial Switch
  • Parents willing and able to sign consent

You may not qualify if:

  • Pulmonary artery or vein abnormalities not being addressed surgically
  • Preoperative requirement for mechanical ventilation or intravenous inotrope support
  • Any condition that might interfere with study objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

  • Barr FE, Tirona RG, Taylor MB, Rice G, Arnold J, Cunningham G, Smith HA, Campbell A, Canter JA, Christian KG, Drinkwater DC, Scholl F, Kavanaugh-McHugh A, Summar ML. Pharmacokinetics and safety of intravenously administered citrulline in children undergoing congenital heart surgery: potential therapy for postoperative pulmonary hypertension. J Thorac Cardiovasc Surg. 2007 Aug;134(2):319-26. doi: 10.1016/j.jtcvs.2007.02.043.

    PMID: 17662768RESULT

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHeart Defects, Congenital

Interventions

Citrulline

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Amino Acids, DiaminoAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Frederick E. Barr, MD, MSCI

    Vanderbilt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Critical Care Faculty

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

December 1, 2003

Primary Completion

January 1, 2006

Study Completion

December 1, 2009

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations

US(1)