search
Back to results

Citrulline in Severe Sepsis

Primary Purpose

Severe Sepsis, Acute Lung Injury

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High Dose Citrulline
Placebo
Low Dose Citrulline
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Sepsis

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Low Dose Citrulline

Placebo

High Dose Citrulline

Arm Description

Low Dose Citrulline

Placebo IV infusion

High Dose Citrulline

Outcomes

Primary Outcome Measures

Vasopressor Dependency Index
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)

Secondary Outcome Measures

Full Information

First Posted
November 11, 2011
Last Updated
June 2, 2017
Sponsor
Vanderbilt University
Collaborators
National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01474863
Brief Title
Citrulline in Severe Sepsis
Official Title
Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous Citrulline to Prevent or Mitigate Acute Lung Injury in Patients With Severe Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Acute Lung Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Citrulline
Arm Type
Active Comparator
Arm Description
Low Dose Citrulline
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo IV infusion
Arm Title
High Dose Citrulline
Arm Type
Active Comparator
Arm Description
High Dose Citrulline
Intervention Type
Drug
Intervention Name(s)
High Dose Citrulline
Intervention Description
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 Type
Drug
Intervention Name(s)
Placebo
Intervention Description
D5W IV fluids at isovolumetric rate (about 15ml/hr)
Intervention Type
Drug
Intervention Name(s)
Low Dose Citrulline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vasopressor Dependency Index
Description
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)
Time Frame
day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Rice, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Citrulline in Severe Sepsis

We'll reach out to this number within 24 hrs