NCT01474863

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Sepsis
• Acute Lung Injury

Interventions

Type	Name	Description
DRUG	High Dose Citrulline	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
DRUG	Placebo	D5W IV fluids at isovolumetric rate (about 15ml/hr)
DRUG	Low Dose Citrulline	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.

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2011-11-18
• Last updated: 2017-06-05
• Results posted: 2017-06-05

Locations

1 site across 1 country: United States