Enteral Versus Parenteral Glutamine Supplement

This study has been terminated.
(Termination due to interim analysis results, inclusion problems in small ICUs.)
Sponsor:
Information provided by (Responsible Party):
Lidija Kompan, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00875797
First received: April 2, 2009
Last updated: December 1, 2013
Last verified: December 2013
Results First Received: June 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Critically Ill
Interventions: Dietary Supplement: parenteral glutamine
Dietary Supplement: enteral glutamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Mechanically ventilated surgical and trauma critically-ill patients, older than 18 years, were enrolled in the study upon admission to ICU.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The patients with anuria or/and intestinal insufficiency (obstruction, discontinuation of intestine or severe paralytic ileus) were excluded from the study

Reporting Groups
  Description
Group P Group P - group with parenterally supplemented glutamine
Group E Group E - group with enterally supplemented glutamine

Participant Flow:   Overall Study
    Group P     Group E  
STARTED     45     45  
COMPLETED     39     42  
NOT COMPLETED     6     3  
Protocol Violation                 6                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mixed surgical ICU population

Reporting Groups
  Description
Parenteral Glutamine parenteral glutamine supplementation
Enteral Glutamine enteral glutamine supplementation
Total Total of all reporting groups

Baseline Measures
    Parenteral Glutamine     Enteral Glutamine     Total  
Number of Participants  
[units: participants]
  45     45     90  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     32     32     64  
>=65 years     13     12     25  
Age  
[units: years]
Mean ± Standard Deviation
  55.97  ± 12.90     51.40  ± 20.19     53.60  ± 17.13  
Gender  
[units: participants]
     
Female     15     14     29  
Male     30     31     61  



  Outcome Measures
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1.  Primary:   Intestinal Permeability - Lactulose-mannitol(L/M)Test   [ Time Frame: 4 days after admission to intensive care unit ]

2.  Secondary:   Infection Rate at Participants in Both Groups   [ Time Frame: participants were followed for the duration of ICU stay (average 3 weeks) ]

3.  Secondary:   6-month Survival   [ Time Frame: 6 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Termination due to small sample size for nutritional pilot study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lidija Kompan, principal Investigator
Organization: UMCLjubljana
phone: 0038651301781
e-mail: lidija.kompan@gmail.com


Publications:

Responsible Party: Lidija Kompan, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00875797     History of Changes
Other Study ID Numbers: P4-0092: onko
Study First Received: April 2, 2009
Results First Received: June 27, 2013
Last Updated: December 1, 2013
Health Authority: Slovenia: Ethics Committee