Phase 2
N=72
Citrulline in Severe Sepsis
Severe Sepsis · Acute Lung Injury
Bottom Line
View on ClinicalTrials.gov: NCT01474863 ↗Enrolled (actual)
72
Serious AEs
18.1%
Results posted
Jun 2017
Primary outcome: Primary: Vasopressor Dependency Index — 50.0; 44.4; 49.0 mmHg/catecholamine index — p=0.86
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- High Dose Citrulline (Drug); Placebo (Drug); Low Dose Citrulline (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vasopressor Dependency Index |
50.0; 44.4; 49.0 | 0.86 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01474863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.