Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Citrulline in Severe Sepsis

This study has been completed.
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: April 26, 2016
Last verified: April 2016

November 11, 2011
April 26, 2016
August 2012
March 2016   (final data collection date for primary outcome measure)
Vasopressor Dependency Index [ Time Frame: day 4 ] [ Designated as safety issue: Yes ]
Index measuring blood pressure hourly through study infusion (day 4)
Same as current
Complete list of historical versions of study NCT01474863 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Citrulline in Severe Sepsis
Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous Citrulline to Prevent or Mitigate Acute Lung Injury in Patients With Severe Sepsis
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Severe Sepsis
  • Acute Lung Injury
  • 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
  • Drug: Placebo
    D5W IV fluids at isovolumetric rate (about 15ml/hr)
  • 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.
  • Active Comparator: Low Dose Citrulline
    Low Dose Citrulline
    Intervention: Drug: Low Dose Citrulline
  • Placebo Comparator: Placebo
    Placebo IV infusion
    Intervention: Drug: Placebo
  • Active Comparator: High Dose Citrulline
    High Dose Citrulline
    Intervention: Drug: High Dose Citrulline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01474863
111435
No
Not Provided
Not Provided
Todd Rice, Vanderbilt University
Vanderbilt University
National Institutes of Health (NIH)
Principal Investigator: Todd Rice, MD Vanderbilt University
Vanderbilt University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP