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| Sponsored by: |
University Medical Centre Ljubljana |
|---|---|
| Information provided by: | University Medical Centre Ljubljana |
| ClinicalTrials.gov Identifier: | NCT00875797 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Comparison of Effect of Enteral Versus Parenteral Glutamine Supplement on Intestinal Permeability and Outcome of Critically Ill Patients |
| 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 |
|---|---|
|
glutamine: Experimental
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Slovenia | |
| General Hospital Slovenj Gradec | |
| Slovenj Gradec, Slovenia | |
| Principal Investigator: | Jasna Uranjek, MD | General Hospital Slovenj Gradec |
More Information
| Responsible Party: | University Medical Centre Ljubljana ( Lidija Kompan ) |
| Study ID Numbers: | P4-0092: onko |
| Study First Received: | April 2, 2009 |
| Last Updated: | April 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00875797 History of Changes |
| Health Authority: | Slovenia: Ethics Committee |
|
enteral parenteral glutamine intestinal permeability infection |
|
Glutamine Critical Illness |
|
Disease Attributes Pathologic Processes Critical Illness |
