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Enteral Glutamine in Critical Illness

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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

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.

Condition or disease Intervention/treatment Phase
Critical Illness Sepsis Respiratory Insufficiency Drug: Glutamine Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Enteral Glutamine Supplementation to Standard of Care Enteral Feeding in Critical Illness
Study Start Date : May 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Will receive enteral glutamine
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)
No Intervention: B
No enteral glutamine given



Primary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
  2. Length of ICU stay [ Time Frame: 28 days ]
  3. Number of Ventilator Days [ Time Frame: 28 days ]
  4. Number of days receiving antibiotics [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Change in APACHE Score [ Time Frame: 72 hours ]
  2. Change in Number of SIRS Criteria [ Time Frame: 72 hours ]
  3. Change in Capillary Leak as measured by blood volume analysis [ Time Frame: 72 hours ]
  4. Change in CRP [ Time Frame: 72 hours ]
  5. Correlation between capillary permeability and APACHE Score [ Time Frame: 72 hours ]
  6. Correlation between capillary permeability and Mortality [ Time Frame: 72 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318331


Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Michael DePietro, M.D.

Publications:

Responsible Party: Dr. Michael DePietro, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00318331     History of Changes
Other Study ID Numbers: Glutamine
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008

Keywords provided by Christiana Care Health Services:
Glutamine
Critical Illness
Enteral Feeding
Blood Volume Analysis

Additional relevant MeSH terms:
Critical Illness
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases