Text Size

Enteral Versus Parenteral Glutamine Supplement

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00875797
First received: April 2, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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: enteral glutamine, parenteral 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:

Drug Information available for: Glutamine
U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Measurement of intestinal permeability using lactulose-mannitol test [ Time Frame: 4 days after admission to intensive care unit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Infection rate and survival [ Time Frame: 6 months survival ] [ Designated as safety issue: Yes ]

Enrollment: 72
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
Experimental: glutamine
Glutamine is a major fuel for the intestinal tract and immune cells and therefore affects the intestinal permeability and infection rate at critically ill patients.
 Dietary Supplement: enteral glutamine, parenteral glutamine
Comparison of enteral versus parenteral glutamine administration at critically ill patients.
Other Name: Dipeptiven, Alitraque

  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
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, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00875797     History of Changes
Other Study ID Numbers: P4-0092: onko
Study First Received: April 2, 2009
Last Updated: April 2, 2009
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 May 16, 2013