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Citrulline in Severe Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01474863
First Posted: November 18, 2011
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University
November 11, 2011
November 18, 2011
March 22, 2017
June 5, 2017
June 5, 2017
August 2012
March 2016   (Final data collection date for primary outcome measure)
Vasopressor Dependency Index [ Time Frame: day 4 ]
Worst Value of Index measuring blood pressure hourly through study infusion (day 4). Vasopressor index is mean arterial blood pressure divided by catecholamine index (the catecholamine index is a dimensionless variable calculated as (dopamine dose × 1) + (dobutamine dose × 1) + (adrenaline dose × 10) + (noradrenaline × 100) + (phenylephrine dose × 100), where all doses are expressed in ug/kg/min). (Higher is better)
Vasopressor Dependency Index [ Time Frame: day 4 ]
Index measuring blood pressure hourly through study infusion (day 4)
Complete list of historical versions of study NCT01474863 on ClinicalTrials.gov Archive Site
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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.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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
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*   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
Sexes Eligible for Study: All
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 Medical Center
Vanderbilt University Medical Center
June 2017

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