Trial record 11 of 23 for:    ARDS OR acute respiratory distress syndrome | Open Studies | NIH, U.S. Fed

Citrulline in Severe Sepsis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Vanderbilt University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01474863
First received: November 11, 2011
Last updated: December 16, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 Vanderbilt University:

Primary Outcome Measures:
  • Vasopressor Dependency Index [ Time Frame: day 4 ] [ Designated as safety issue: Yes ]
    Index measuring blood pressure hourly through study infusion (day 4)


Estimated Enrollment: 75
Study Start Date: August 2012
Estimated Primary Completion Date: July 2014 (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
Genders Eligible for Study:   Both
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 Recruiting
Nashville, Tennessee, United States, 37232
Contact: Todd W Rice, MD, MSc       todd.rice@vanderbilt.edu   
Principal Investigator: Todd Rice, MD         
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

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
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014