Citrulline in Severe Sepsis

PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Severe SepsisAcute Lung Injury
Interventions
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.

Trial Locations (1)

37232

Vanderbilt University, Nashville

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

Vanderbilt University

OTHER

NCT01474863 - Citrulline in Severe Sepsis | Biotech Hunter | Biotech Hunter