Citrulline in Severe Sepsis

Vanderbilt University

Status and phase: Completed; Phase 2

Conditions: Acute Lung Injury; Severe Sepsis

Treatments: Drug: Low Dose Citrulline; Drug: Placebo; Drug: High Dose Citrulline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01474863

111435

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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72 participants in 3 patient groups, including a placebo group

Low Dose Citrulline

Active Comparator group

Description:

Low Dose Citrulline

Treatment:

Drug: Low Dose Citrulline

Placebo

Placebo Comparator group

Description:

Placebo IV infusion

Treatment:

Drug: Placebo

High Dose Citrulline

Active Comparator group

Description:

High Dose Citrulline

Treatment:

Drug: High Dose Citrulline