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.

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