Citrulline in Severe Sepsis

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Collaborator: National Institutes of Health (NIH)

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