Conditions: Severe Sepsis Acute Lung Injury
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 72
Healthy volunteers: no

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:

Arms:
arm 1: Low Dose Citrulline arm 2: Placebo IV infusion arm 3: High Dose Citrulline

Interventions: intervention 1: High Dose Citrulline intervention 2: Placebo intervention 3: Low Dose Citrulline
Intervention descriptions: intervention 1: 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 intervention 2: D5W IV fluids at isovolumetric rate (about 15ml/hr) intervention 3: 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.

Protocol document: