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

Tracking Information
First Received Date ^ICMJE	November 11, 2011
Last Updated Date	June 19, 2012
Start Date ^ICMJE	August 2012
Estimated Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 17, 2011)	Vasopressor Dependency Index [ Time Frame: day 4 ] [ Designated as safety issue: Yes ] Index measuring blood pressure hourly through study infusion (day 4)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01474863 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Citrulline in Severe Sepsis
Official Title ^ICMJE	Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous Citrulline to Prevent or Mitigate Acute Lung Injury in Patients With Severe Sepsis
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Severe Sepsis Acute Lung Injury
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	75
Completion Date	Not Provided
Estimated Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01474863
Other Study ID Numbers ^ICMJE	111435
Has Data Monitoring Committee	No
Responsible Party	Todd Rice, Vanderbilt University
Study Sponsor ^ICMJE	Vanderbilt University
Collaborators ^ICMJE	National Institutes of Health (NIH)
Investigators ^ICMJE	Not Provided
Information Provided By	Vanderbilt University
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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