Enteral Versus Parenteral Glutamine Supplement
This study has been completed.
Sponsor:
University Medical Centre Ljubljana
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
| Tracking Information | |||||
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| First Received Date ICMJE | April 2, 2009 | ||||
| Last Updated Date | April 2, 2009 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Measurement of intestinal permeability using lactulose-mannitol test [ Time Frame: 4 days after admission to intensive care unit ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Infection rate and survival [ Time Frame: 6 months survival ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Enteral Versus Parenteral Glutamine Supplement | ||||
| Official Title ICMJE | Comparison of Effect of Enteral Versus Parenteral Glutamine Supplement on Intestinal Permeability and Outcome of Critically Ill Patients | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Critically Ill | ||||
| Intervention ICMJE | Dietary Supplement: enteral glutamine, parenteral glutamine
Comparison of enteral versus parenteral glutamine administration at critically ill patients.
Other Name: Dipeptiven, Alitraque |
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| Study Arm (s) | 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.
Intervention: Dietary Supplement: enteral glutamine, parenteral glutamine |
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| Publications * | Luo M, Bazargan N, Griffith DP, Estívariz CF, Leader LM, Easley KA, Daignault NM, Hao L, Meddings JB, Galloway JR, Blumberg JB, Jones DP, Ziegler TR. Metabolic effects of enteral versus parenteral alanyl-glutamine dipeptide administration in critically ill patients receiving enteral feeding: a pilot study. Clin Nutr. 2008 Apr;27(2):297-306. Epub 2008 Feb 7. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 72 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Slovenia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00875797 | ||||
| Other Study ID Numbers ICMJE | P4-0092: onko | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lidija Kompan, University Medical Centre Ljubljana | ||||
| Study Sponsor ICMJE | University Medical Centre Ljubljana | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Medical Centre Ljubljana | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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