Citrulline in Severe Sepsis

Phase 2

Completed

• Conditions: Severe Sepsis; Acute Lung Injury
• Interventions: Drug: Low Dose Citrulline; Drug: Placebo; Drug: High Dose Citrulline

• Registration Number: NCT01474863
• Lead Sponsor: Vanderbilt University

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

Not available

Study Timeline

• Study First Submitted: 2011-11-11
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-18
• Study Start: 2012-08
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-03-22
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-02
• Last Update Submitted: 2017-06-02
• Results First Posted: 2017-06-05
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Dose Citrulline	Low Dose Citrulline	Low Dose Citrulline
Placebo	Placebo	Placebo IV infusion
High Dose Citrulline	High Dose Citrulline	High Dose Citrulline

Primary Outcome Measures

Name	Time	Method
Vasopressor Dependency Index	day 4	Worst Value of Index measuring blood pressure hourly through study infusion (day 4). Vasopressor index is mean arterial blood pressure divided by catecholamine index (the catecholamine index is a dimensionless variable calculated as (dopamine dose × 1) + (dobutamine dose × 1) + (adrenaline dose × 10) + (noradrenaline × 100) + (phenylephrine dose × 100), where all doses are expressed in ug/kg/min). (Higher is better)

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States