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Enteral Versus Parenteral Glutamine Supplement

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ClinicalTrials.gov 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
Sponsor:
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
Enrollment 90
Recruitment Details Mechanically ventilated surgical and trauma critically-ill patients, older than 18 years, were enrolled in the study upon admission to ICU.
Pre-assignment Details The patients with anuria or/and intestinal insufficiency (obstruction, discontinuation of intestine or severe paralytic ileus) were excluded from the study
Arm/Group Title Group P Group E
Hide Arm/Group Description Group P - group with parenterally supplemented glutamine Group E - group with enterally supplemented glutamine
Period Title: Overall Study
Started 45 45
Completed 39 42
Not Completed 6 3
Reason Not Completed
Protocol Violation             6             3
Arm/Group Title Parenteral Glutamine Enteral Glutamine Total
Hide Arm/Group Description parenteral glutamine supplementation enteral glutamine supplementation Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
mixed surgical ICU population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
<=18 years
0
   0.0%
1
   2.2%
1
   1.1%
Between 18 and 65 years
32
  71.1%
32
  71.1%
64
  71.1%
>=65 years
13
  28.9%
12
  26.7%
25
  27.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
55.97  (12.90) 51.40  (20.19) 53.60  (17.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
15
  33.3%
14
  31.1%
29
  32.2%
Male
30
  66.7%
31
  68.9%
61
  67.8%
1.Primary Outcome
Title Intestinal Permeability - Lactulose-mannitol(L/M)Test
Hide Description

Measurement of intestinal permeability using lactulose-mannitol test (L/M test).

Intestinal permeability to sugars is an accurate test for detecting intestinal damage. Intestinal permeability of the epithelium to very small sugar molecules such as lactulose/mannitol may give useful information regarding the overall condition of the digestive tract.

Mannitol is absorbed transcellularly and lactulose has a paracellular route of absorption. Reduction in mannitol absorption shows reduced surface area and increased lactulose absorption indicates a leaky gut.

Lactulose and mannitol are given orally and later determined from the collected urine with HPTLC (high performance thin layer chromatography). The L/M ratio, as a result of lactulose-mannitol tests, is then calculated regarding urine lactulose and mannitol concentrations.

Thus, with the lactulose/mannitol test the intestinal permeability changes due to different reasons can be evaluated.

Time Frame 4 days after admission to intensive care unit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group P - Parenteral Glutamine Group E - Enteral Glutamine
Hide Arm/Group Description:
Group P - group with parenterally supplemented glutamine
Group E - group with enterally supplemented glutamine
Overall Number of Participants Analyzed 39 42
Mean (Standard Deviation)
Unit of Measure: L/M ratio
0.492  (0.68) 0.521  (0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group P - Parenteral Glutamine, Group E - Enteral Glutamine
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments t-test
Statistical Test of Hypothesis P-Value 0.05
Comments p<0.05
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Infection Rate at Participants in Both Groups
Hide Description Number of infections that occured at participants during study.
Time Frame participants were followed for the duration of ICU stay (average 3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group P - Parenteral Glutamine Group - Enteral Glutamine
Hide Arm/Group Description:
Group P - group with parenterally supplemented glutamine
Group E - group with enterally supplemented glutamine
Overall Number of Participants Analyzed 39 42
Measure Type: Number
Unit of Measure: number of infections
15 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group P - Parenteral Glutamine, Group - Enteral Glutamine
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments χ2 test
Statistical Test of Hypothesis P-Value 0.05
Comments p<0.05
Method Chi-squared
Comments 2 degrees of freedom
Method of Estimation Estimation Parameter percentage of infection
Estimated Value 20
Parameter Dispersion
Type: Standard Deviation
Value: 10
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 6-month Survival
Hide Description Six month follow up
Time Frame 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group P - Parenteral Glutamine Group E - Enteral Glutamine
Hide Arm/Group Description:
parenteral glutamine supplementation
enteral glutamine supplementation
Overall Number of Participants Analyzed 39 42
Measure Type: Number
Unit of Measure: participants
31 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group P - Parenteral Glutamine, Group E - Enteral Glutamine
Comments Chi-square
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments p<0.05
Method Chi-squared, Corrected
Comments 2-degrees of freedom
Method of Estimation Estimation Parameter percentage of survivers
Estimated Value 80
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group P Group E
Hide Arm/Group Description Group P - group with parenterally supplemented glutamine Group E - group with enterally supplemented glutamine
All-Cause Mortality
Group P Group E
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group P Group E
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group P Group E
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Termination due to small sample size for nutritional pilot study.
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
ClinicalTrials.gov 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