Enteral Glutamine in Critical Illness

This study has been terminated.
(Unable to meet enrollment numbers)
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00318331
First received: April 24, 2006
Last updated: March 10, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Critical Illness
Sepsis
Respiratory Insufficiency
Drug: Glutamine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Enteral Glutamine Supplementation to Standard of Care Enteral Feeding in Critical Illness

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Length of ICU stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Ventilator Days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of days receiving antibiotics [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in APACHE Score [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Change in Number of SIRS Criteria [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Change in Capillary Leak as measured by blood volume analysis [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Change in CRP [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Correlation between capillary permeability and APACHE Score [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Correlation between capillary permeability and Mortality [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: Glutamine
No Intervention: B
No enteral glutamine given

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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.
  More Information

Publications:

Responsible Party: Dr. Michael DePietro, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00318331     History of Changes
Other Study ID Numbers: Glutamine
Study First Received: April 24, 2006
Last Updated: March 10, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 21, 2014