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Citrulline in Severe Sepsis

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01474863
First received: November 11, 2011
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Severe Sepsis Acute Lung Injury Drug: High Dose Citrulline Drug: Placebo Drug: Low Dose Citrulline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Todd Rice, Vanderbilt University:

Primary Outcome Measures:
  • Vasopressor Dependency Index [ Time Frame: 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)


Enrollment: 72
Study Start Date: August 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Dose Citrulline
Low Dose Citrulline
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.
Placebo Comparator: Placebo
Placebo IV infusion
Drug: Placebo
D5W IV fluids at isovolumetric rate (about 15ml/hr)
Active Comparator: High Dose Citrulline
High Dose Citrulline
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

  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474863

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Todd Rice, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Todd Rice, Assistant Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01474863     History of Changes
Other Study ID Numbers: 111435
Study First Received: November 11, 2011
Results First Received: March 22, 2017
Last Updated: June 2, 2017

Additional relevant MeSH terms:
Sepsis
Toxemia
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders

ClinicalTrials.gov processed this record on July 26, 2017