Enteral Versus Parenteral Glutamine Supplement

NCT00875797 | Terminated Phase 4 Results DMC

• 1 other identifier: P4-0092: onko
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

enteral; parenteral; glutamine; intestinal permeability; infection

Outcome Measures

Primary Outcomes (1)

• Intestinal Permeability - Lactulose-mannitol(L/M)Test

  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.

  4 days after admission to intensive care unit

Secondary Outcomes (2)

• Infection Rate at Participants in Both Groups

  participants were followed for the duration of ICU stay (average 3 weeks)

• 6-month Survival

  6 month

Study Arms (2)

parentral glutamine

ACTIVE COMPARATOR

parenteral glutamine given in central venous line in dose up to 30 g par day

Dietary Supplement: parenteral glutamine

entral glutamine

EXPERIMENTAL

enteral glutamine given through gastric tube in a dose up to 30 g per day

Dietary Supplement: enteral glutamine

Interventions

parenteral glutamine DIETARY_SUPPLEMENT

Dipeptiven, Fresenius Kabi, Graz, Austria was given intravenously through central venous line in a dose up to 30 g per day

Also known as: Dipeptiven, Fresenius Kabi, Graz, Austria

parentral glutamine

enteral glutamine DIETARY_SUPPLEMENT

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

Also known as: Alitraq, Abbott Laboratories, B.W. Zwolle, the Netherlands

entral glutamine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

General Hospital Slovenj Gradec

Slovenj Gradec, Slovenia

Location

Related Publications (1)

• Luo M, Bazargan N, Griffith DP, Estivariz 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. doi: 10.1016/j.clnu.2007.12.003. Epub 2008 Feb 7.

  PMID: 18258342 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Infections

Interventions

alanylglutamine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Termination due to small sample size for nutritional pilot study.

Results Point of Contact

• Title: Lidija Kompan, principal Investigator
• Organization: UMCLjubljana

lidija.kompan@gmail.com

0038651301781

Study Officials

• Jasna Uranjek, MD

  General Hospital Slovenj Gradec

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: October 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 16, 2014
• Results First Posted: January 16, 2014

Record last verified: 2013-12

Locations

SL (1)