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
  Purpose

Glutamine is a major fuel for the intestinal tract and immune cells and therefore affects the intestinal permeability (IP) and infection rate at critically ill patients. The preferential route of glutamine supplementation at critically ill patients still remains open. Therefore the researchers will investigate IP, infection rate and treatment outcome at patients supplemented with either parenteral or enteral glutamine.

A prospective randomized single blind study is performed at mechanically ventilated. Patients were randomly assigned to either parenteral (group P) or enteral (group E) glutamine supplemented group. Early enteral feeding is started in both groups. Patients are/will be treated with glutamine for five days. IP will be measured using lactulose/mannitol test (L/M) on the fourth day.


Condition Intervention Phase
Critically Ill
Dietary Supplement: parenteral glutamine
Dietary Supplement: enteral glutamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Effect of Enteral Versus Parenteral Glutamine Supplement on Intestinal Permeability and Outcome of Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Intestinal Permeability - Lactulose-mannitol(L/M)Test [ Time Frame: 4 days after admission to intensive care unit ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Infection Rate at Participants in Both Groups [ Time Frame: participants were followed for the duration of ICU stay (average 3 weeks) ] [ Designated as safety issue: Yes ]
    Number of infections that occured at participants during study.

  • 6-month Survival [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Six month follow up


Enrollment: 90
Study Start Date: October 2004
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: parentral glutamine
parenteral glutamine given in central venous line in dose up to 30 g par day
Dietary Supplement: parenteral glutamine
Dipeptiven, Fresenius Kabi, Graz, Austria was given intravenously through central venous line in a dose up to 30 g per day
Other Name: Dipeptiven, Fresenius Kabi, Graz, Austria
Experimental: entral glutamine
enteral glutamine given through gastric tube in a dose up to 30 g per day
Dietary Supplement: enteral glutamine
Alitraq, Abbott Laboratories, B.W. Zwolle, the Netherlands was given via nasogastric tube as continuous infusion of enteral diet, dose up to 30 g per day
Other Name: Alitraq, Abbott Laboratories, B.W. Zwolle, the Netherlands

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mechanically ventilated critically-ill patients
  • older than 18 years
  • staying in intensive care unit for at least 4 days

Exclusion Criteria:

  • anuria
  • intestinal insufficiency (obstruction, discontinuation of intestine or severe ileus)
  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: NCT00875797

Locations
Slovenia
General Hospital Slovenj Gradec
Slovenj Gradec, Slovenia
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Principal Investigator: Jasna Uranjek, MD General Hospital Slovenj Gradec
  More Information

Publications:
Responsible Party: Lidija Kompan, MD, PhD, 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

Keywords provided by University Medical Centre Ljubljana:
enteral
parenteral
glutamine
intestinal permeability
infection

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014