Status:
COMPLETED
Citrulline in Severe Sepsis
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Severe Sepsis
Acute Lung Injury
Eligibility:
All Genders
13+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Severe Sepsis
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01474863
Start Date
August 1 2012
End Date
March 1 2016
Last Update
June 5 2017
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232