A Randomized Controlled Trial of Glutamine Dipeptide in Severe Trauma (GLND Trauma)

This study is not yet open for participant recruitment.
Verified January 2013 by Ziegler, Thomas R., M.D.
Sponsor:
Information provided by (Responsible Party):
Ziegler, Thomas R., M.D.
ClinicalTrials.gov Identifier:
NCT01776476
First received: January 17, 2013
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to find out if giving certain amino acids to critically injured patients can improve their condition or recovery, and lower their blood sugar and insulin needs. Amino acids are the 'building blocks' of proteins. The amino acid compound used in this study is called alanyl-glutamine dipeptide, also known as Dipeptiven® or glutamine. Glutamine is investigational, meaning not approved by the Food and Drug Administration (FDA) for intravenous use. However, it is approved by many countries in Europe, Asia and South America. Several studies suggest that giving glutamine has certain benefits in patients who need intensive care. In a study done at Emory University Medical Center using the same dose of glutamine, the number of hospital infections was lower in patients who had had cardiac, blood vessel or intestinal surgery compared to similar patients who received standard feedings without glutamine. No side effects were thought to be due to giving glutamine in that small study. This study is only being done at Vanderbilt University. The investigators plan to enroll 24 patients in the Trauma ICU over the next 12 months.


Condition Intervention Phase
Stress Hyperglycemia
Insulin Resistance
Trauma
Critical Illness
Drug: Glutamine
Other: Placebo
Procedure: Surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Glutamine Dipeptide in Severe Trauma

Resource links provided by NLM:


Further study details as provided by Ziegler, Thomas R., M.D.:

Primary Outcome Measures:
  • Change of insulin resistance by euglycemic hyperinsulinemic clamp [ Time Frame: Day 2 and Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surrogate measures of glucose metabolism [ Time Frame: Day 1-Day 30 ] [ Designated as safety issue: No ]
    Blood glucose, insulin infusion rate, mean kcal of glycemic provision, insulin multiplier


Other Outcome Measures:
  • Mortality [ Time Frame: Day 1-day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: February 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
normal saline of equivalent volume to the experimental drug infusion administered as a continuous infusion over 24 hours for up to 7 days or ICU discharge, whichever comes first.
Other: Placebo
normal saline of equivalent volume to the experimental drug infusion administered as a continuous infusion over 24 hours for up to 7 days or ICU discharge, whichever comes first
Procedure: Surgery
Experimental: Glutamine
Glutamine dipeptide 0.5 gm/kg/day will be administered as a continuous infusion over 24 hours for up to 7 days or ICU discharge, whichever comes first.
Drug: Glutamine
Glutamine dipeptide 0.5 gm/kg/day will be administered as a continuous infusion over 24 hours for up to 7 days or ICU discharge, whichever comes first.
Other Name: Glutamine Dipeptide
Procedure: Surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Severe trauma (ISS > 16) no more than 24 hours prior to initiation of study drug
  2. Mechanical Ventilation
  3. Blood transfusion OR inotropic support prior to enrollment
  4. Estimated BMI <40.0 kg/m2

Exclusion Criteria:

  1. Moribund patients, unlikely to survive 24 hours
  2. Anticipated ICU stay < 48 hours
  3. Pre-existing diabetes mellitus
  4. Known allergy to the drug or any components
  5. Known pregnancy
  6. Corticosteroid administration prior to enrollment
  7. Severe traumatic brain injury or uncontrolled intracranial hypertension
  8. Current malignancy
  9. History of seizures, chronic liver disease, chronic renal failure requiring dialysis or solid organ transplantation
  10. Known HIV/AIDS
  11. Known treatment with another investigational product within 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776476

Contacts
Contact: Addison K May, MD FACS FCCM 615-936-7188
Contact: Kaushik Mukherjee, MD MSCI

Locations
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Addison K May, MD FACS FCCM    615-936-7188    addison.may@vanderbilt.edu   
Contact: Kaushik Mukherjee, MD MSCI    615-936-2953    kaushik.mukherjee@vanderbilt.edu   
Sponsors and Collaborators
Ziegler, Thomas R., M.D.
Investigators
Principal Investigator: Addison K May, MD FACS FCCM Vanderbilt University
  More Information

No publications provided

Responsible Party: Ziegler, Thomas R., M.D.
ClinicalTrials.gov Identifier: NCT01776476     History of Changes
Other Study ID Numbers: VR2278, UL1TR000445
Study First Received: January 17, 2013
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ziegler, Thomas R., M.D.:
glutamine dipeptide
randomized controlled trial
insulin resistance
critical illness
trauma

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Insulin Resistance
Wounds and Injuries
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on April 23, 2014