Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery

NCT00335244 | Completed Phase 3 DMC

• 3 other identifiers: 409R01HL073317-01IRB# 060197
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Defects, Congenital; Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative mechanical ventilation in hours compared between treatment groups.

  Measured in hours from the end of surgery until extubation

Secondary Outcomes (6)

• Incidence of increased PVT (defined as a sustained mean pulmonary artery pressure greater than 20 mm Hg for at least 2 hours, measured during the first 48 hours

  Measured in hours from the end of surgery until extubation

• Postoperative intravenous inotrope score

  Measured at 48 hours

• Length and volume of chest tube drainage

  Measured in hours from the end of surgery until removal of chest tubes

• Length of ICU stay

  Measured in hours from the end of surgery to discharge from ICU

• Length of hospitalization

  Measured from the day of surgery until discharge from hospital

Study Arms (2)

1

EXPERIMENTAL

Intravenous L-citrulline

Drug: L-citrulline

2

PLACEBO COMPARATOR

Placebo of intravenous L-citrulline

Drug: Placebo of intravenous L-citrulline

Interventions

L-citrulline DRUG

150mg bolus X 1 after initiation of cardiopulmonary bypass followed by continuous infusion of 9mg/kg/hr IV, starting 4 hours post bolus administration and ending at 48 hours continuous infusion or discharge from the PCCU

1

Placebo of intravenous L-citrulline DRUG

Placebo of intravenous L-citrulline

2

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Undergoing cardiopulmonary bypass surgery with 1 of the following 5 procedures:
• AVSD repair
• VSD repair
• Bidirectional Glenn
• Modified Fontan
• Arterial switch

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, as determined by the investigator
• Pregnant

Sponsors & Collaborators

• Asklepion Pharmaceuticals, LLC: lead
• Vanderbilt University: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Hypertension, Pulmonary

Interventions

Citrulline

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Fredrick E. Barr, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 9, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

US (1)