Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients
October 13, 2018 updated by: Zahra Vahdat Shariatpanahi, Shahid Beheshti University
Effects of Enteral Glutamine on Inflammatory Response, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill patients, possibly in part through an attenuation of the proinflammatory cytokine response and a Immune function.
In this trial intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 28 days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran.
After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed.
The participants are 200 eligible hospitalized patients with enteral feeding in ICU, aged ≥ 18 years.
Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral formula for 28 days and control patients will be received maltodextrin along with enteral formula for 28 days.
Patients will be evaluated for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tehran, Iran, Islamic Republic of
- Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
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Tehran, Iran, Islamic Republic of
- Shohada Tajrish Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients (>18 years old) admitted to ICU
- Start of study intervention within 48 hours after ICU admission
- Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
- Written informed consent of patient or written informed consent of legal representative
Exclusion Criteria:
- Enrollment in a related ICU interventional study
- Requiring other specific enteral nutrition for medical reason
- Death or Discharge before 5th day
- Having any contra-indication to receive enteral nutrition
- Pregnant patients or lactating with the intent to breastfeed
- Requiring other specific enteral nutrition for medical reason
- BMI <18 or > 40.0 kg/m2
- Have life expectancy of <6 mo
- Patients who are moribond
- Liver cirrhosis- Child's class C liver disease
- Have seizure disorder requiring anticonvulsant
- History of allergy or intolerance to the study product components
- Receiving glutamine during two weeks before start study product
- Have other reasons
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Glutamin
Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.
|
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs
Other Names:
|
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PLACEBO_COMPARATOR: maltodextrin
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
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Maltodextrin mixed with water given via NG tube Q 4 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of infection
Time Frame: Day 28
|
Incidence of infections
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum Inflammatory Markers
Time Frame: baseline, Day 5, Day 10
|
Inflammatory factors
|
baseline, Day 5, Day 10
|
|
Serum Immunity Markers
Time Frame: baseline, Day 5, Day 10
|
baseline, Day 5, Day 10
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|
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Length of stay in ICU
Time Frame: Day 28
|
Day 28
|
|
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28-day Mortality
Time Frame: Day 28
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Day 28
|
Day 28
|
|
6-month mortality
Time Frame: month 6
|
month 6
|
month 6
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum Glutamin
Time Frame: baseline, Day 5, Day 10
|
baseline, Day 5, Day 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Zahra Vahdat Shariatpanahi, MD, PhD, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hall JC, Dobb G, Hall J, de Sousa R, Brennan L, McCauley R. A prospective randomized trial of enteral glutamine in critical illness. Intensive Care Med. 2003 Oct;29(10):1710-6. doi: 10.1007/s00134-003-1937-2. Epub 2003 Aug 16.
- McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available. Erratum In: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200.
- Heyland D, Muscedere J, Wischmeyer PE, Cook D, Jones G, Albert M, Elke G, Berger MM, Day AG; Canadian Critical Care Trials Group. A randomized trial of glutamine and antioxidants in critically ill patients. N Engl J Med. 2013 Apr 18;368(16):1489-97. doi: 10.1056/NEJMoa1212722. Erratum In: N Engl J Med. 2013 May 9;368(19):1853. Dosage error in article text.
- van Zanten AR, Sztark F, Kaisers UX, Zielmann S, Felbinger TW, Sablotzki AR, De Waele JJ, Timsit JF, Honing ML, Keh D, Vincent JL, Zazzo JF, Fijn HB, Petit L, Preiser JC, van Horssen PJ, Hofman Z. High-protein enteral nutrition enriched with immune-modulating nutrients vs standard high-protein enteral nutrition and nosocomial infections in the ICU: a randomized clinical trial. JAMA. 2014 Aug 6;312(5):514-24. doi: 10.1001/jama.2014.7698.
- Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, Nitenberg G, van den Berghe G, Wernerman J; DGEM (German Society for Nutritional Medicine); Ebner C, Hartl W, Heymann C, Spies C; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr. 2006 Apr;25(2):210-23. doi: 10.1016/j.clnu.2006.01.021. Epub 2006 May 11.
- McQuiggan M, Kozar R, Sailors RM, Ahn C, McKinley B, Moore F. Enteral glutamine during active shock resuscitation is safe and enhances tolerance of enteral feeding. JPEN J Parenter Enteral Nutr. 2008 Jan-Feb;32(1):28-35. doi: 10.1177/014860710803200128.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 10, 2016
Primary Completion (ACTUAL)
August 25, 2018
Study Completion (ACTUAL)
September 10, 2018
Study Registration Dates
First Submitted
December 14, 2016
First Submitted That Met QC Criteria
December 16, 2016
First Posted (ESTIMATE)
December 21, 2016
Study Record Updates
Last Update Posted (ACTUAL)
October 16, 2018
Last Update Submitted That Met QC Criteria
October 13, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1395/670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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