Enteral Versus Parenteral Glutamine Supplement

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. Identifier: NCT00875797
Recruitment Status : Terminated (Termination due to interim analysis results, inclusion problems in small ICUs.)
First Posted : April 3, 2009
Results First Posted : January 16, 2014
Last Update Posted : January 16, 2014
Information provided by (Responsible Party):
Lidija Kompan, University Medical Centre Ljubljana

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Critically Ill
Interventions: Dietary Supplement: parenteral glutamine
Dietary Supplement: enteral glutamine

  Participant Flow

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
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 
Protocol Violation                6                3 

  Baseline Characteristics

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

Baseline Measures
   Parenteral Glutamine   Enteral Glutamine   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   45   90 
[Units: Participants]
<=18 years   0   1   1 
Between 18 and 65 years   32   32   64 
>=65 years   13   12   25 
[Units: Years]
Mean (Standard Deviation)
 55.97  (12.90)   51.40  (20.19)   53.60  (17.13) 
[Units: Participants]
Female   15   14   29 
Male   30   31   61 

  Outcome Measures

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

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

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


Responsible Party: Lidija Kompan, University Medical Centre Ljubljana Identifier: NCT00875797     History of Changes
Other Study ID Numbers: P4-0092: onko
First Submitted: April 2, 2009
First Posted: April 3, 2009
Results First Submitted: June 27, 2013
Results First Posted: January 16, 2014
Last Update Posted: January 16, 2014