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Citrulline in Severe Sepsis

This study is not yet open for participant recruitment.
Verified June 2012 by Vanderbilt University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01474863
First received: November 11, 2011
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis is that intravenous L-citrulline will decreased the development or progression of acute lung injury in patients with severe sepsis compared to placebo.


Condition Intervention Phase
Severe Sepsis
Acute Lung Injury
 Drug: High Dose Citrulline
Drug: Placebo
Drug: Low Dose Citrulline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous Citrulline to Prevent or Mitigate Acute Lung Injury in Patients With Severe Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Vasopressor Dependency Index [ Time Frame: day 4 ] [ Designated as safety issue: Yes ]
    Index measuring blood pressure hourly through study infusion (day 4)


Estimated Enrollment: 75
Study Start Date: August 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Dose Citrulline
Low Dose Citrulline
 Drug: Low Dose Citrulline
Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days.
Placebo Comparator: Placebo
Placebo IV infusion
 Drug: Placebo
D5W IV fluids at isovolumetric rate (about 15ml/hr)
Active Comparator: High Dose Citrulline
High Dose Citrulline
 Drug: High Dose Citrulline
Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe Sepsis

Exclusion Criteria:

  • No Consent
  • Malignant or other irreversible condition
  • Moribund and not expected to survive 48 hours
  • End Stage Liver Disease
  • Enrolled in another IND study
  • Pregnant or breast feeding female
  • Age<13 years old
  • Allergy to citrulline or arginine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474863

Locations
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Todd W Rice, MD, MSc         todd.rice@vanderbilt.edu    
Sponsors and Collaborators
Vanderbilt University
National Institutes of Health (NIH)
  More Information

No publications provided

Responsible Party: Todd Rice, Assistant Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01474863     History of Changes
Other Study ID Numbers: 111435
Study First Received: November 11, 2011
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sepsis
Toxemia
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013