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Enteral Glutamine in Critical Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00318331
Recruitment Status : Terminated (Unable to meet enrollment numbers)
First Posted : April 26, 2006
Last Update Posted : March 13, 2008
Sponsor:
Information provided by:
Christiana Care Health Services

Tracking Information
First Submitted Date  ICMJE April 24, 2006
First Posted Date  ICMJE April 26, 2006
Last Update Posted Date March 13, 2008
Study Start Date  ICMJE May 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
  • Mortality [ Time Frame: 28 days ]
  • Length of ICU stay [ Time Frame: 28 days ]
  • Number of Ventilator Days [ Time Frame: 28 days ]
  • Number of days receiving antibiotics [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2006)
  • Mortality
  • Length of ICU stay
  • Number of Ventilator Days
  • Number of days receiving antibiotics
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
  • Change in APACHE Score [ Time Frame: 72 hours ]
  • Change in Number of SIRS Criteria [ Time Frame: 72 hours ]
  • Change in Capillary Leak as measured by blood volume analysis [ Time Frame: 72 hours ]
  • Change in CRP [ Time Frame: 72 hours ]
  • Correlation between capillary permeability and APACHE Score [ Time Frame: 72 hours ]
  • Correlation between capillary permeability and Mortality [ Time Frame: 72 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2006)
  • Change in APACHE Score
  • Change in Number of SIRS Criteria
  • Change in Capillary Leak as measured by blood volume analysis
  • Change in CRP
  • Correlation between capillary permeability and APACHE Score
  • Correlation between capillary permeability and Mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enteral Glutamine in Critical Illness
Official Title  ICMJE Randomized Clinical Trial Comparing Enteral Glutamine Supplementation to Standard of Care Enteral Feeding in Critical Illness
Brief Summary Glutamine is an amino acid which is rapidly depleted in critical illness. It is used as energy by cells that line the gut, vital for immune system function, and works as an anti-oxidant. Glutamine supplementation has been shown to improve outcomes in ICU patients. We hypothesize that critically ill patients given extra glutamine will have less of an inflammatory response and therefore better outcomes than patients not given extra glutamine. Our study randomizes patients to tube feeding with OR without extra glutamine to see if it affects patient outcomes as well as markers of inflammation.
Detailed Description

Glutamine, a nonessential amino acid, is preferred fuel for rapidly proliferating cells in human body. Those cells include the enterocytes in small intestine, lymphocytes, macrophages, and fibroblasts. Glutamine also transports nitrogen between tissues and serves as a precursor to glutathione which is a potent antioxidant. A healthy human body contains abundant glutamine, either from diet or from skeletal muscle tissue that synthesizes it.

During critical illness the demand for glutamine is increased. Rapid depletion of glutamine stores in critically ill patients has been described and correlated to increased mortality. Glutamine depletion may be deleterious in critical illness because of adverse effects on the essential functions mentioned above. For example glutamine depletion may cause gut mucosal barrier function to deteriorate, leading to bacterial translocation and enhanced systemic inflammatory response with increased risk for multisystem organ failure. Clinical trials performed in a wide range of patients with serious illness, including cancer, trauma, burn, major surgery and critical illness, have demonstrated possible benefits of glutamine supplementation. Interpretation of the results of multiple studies is made difficult based on differences in glutamine dosing, route of administration, population studied, and endpoints used.

Blood volume analysis has been shown to be a good measure of capillary leak. The DAXOR blood volume analyzer kit was recently approved by the FDA for blood volume analyses and also has the capacity of measuring capillary permeability by looking at the slope of albumin transudation. It is a simpler way to measure capillary permeability than other methods described.

Reviewing the previous study results, glutamine supplementation in parental form and with higher dose in various patient populations has shown evidence of being beneficial. Studies of enteral glutamine therapy have also showed benefits, but results are less consistent possibly because of the heterogeneous study methodology described above. Moreover, most of the studies are carried out in burn patients and surgical patients; there were few studies in critical ill medical patients. Finally no study has specifically looked at the mechanism via which glutamine has conferred protection.

Comparison: Critically ill patients given enteral tube feeds compared to critically ill patients given enteral tube feeds with supplemental glutamine.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Illness
  • Sepsis
  • Respiratory Insufficiency
Intervention  ICMJE Drug: Glutamine
Group A patients will receive 0.5g/kg/day of enteral glutamine daily while they are receiving tube feeds or at the end of 28 days (whichever comes first)
Study Arms  ICMJE
  • Active Comparator: A
    Will receive enteral glutamine
    Intervention: Drug: Glutamine
  • No Intervention: B
    No enteral glutamine given
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 10, 2008)
20
Original Enrollment  ICMJE
 (submitted: April 24, 2006)
50
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Admission to MICU/ CICU
  • Age greater than or equal to 18 years old
  • Requirement for enteral nutrition
  • Presence or planned insertion of central venous catheter as part of routine medical care
  • Requirement for mechanical ventilation
  • APACHE II Score >/= 15

Exclusion Criteria:

  • Female of child-bearing age (i.e. less than 45 years old)
  • Enteral nutrition begun prior to randomization
  • Receiving Total Parenteral Nutrition
  • Requirement for protein restriction
  • Creatinine >4 mg/dl
  • History of cirrhosis and/or clinical signs of heptic encephalopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00318331
Other Study ID Numbers  ICMJE Glutamine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Michael DePietro, Christiana Care Health Services
Study Sponsor  ICMJE Christiana Care Health Services
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael DePietro, M.D.
PRS Account Christiana Care Health Services
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP