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Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Primary Purpose

Critical Illness, Enteral Nutrition, Multiple Organ Failure

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Glutamin
Maltodextrin
Sponsored by
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Glutamin, Enteral Nutrition, Intensive Care Unit, Critical Care Outcomes, inflammatory, Immune System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
  • Shohada Tajrish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glutamin

maltodextrin

Arm Description

Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.

Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

Outcomes

Primary Outcome Measures

Occurrence of infection
Incidence of infections

Secondary Outcome Measures

Serum Inflammatory Markers
Inflammatory factors
Serum Immunity Markers
Length of stay in ICU
28-day Mortality
Day 28
6-month mortality
month 6

Full Information

First Posted
December 14, 2016
Last Updated
October 13, 2018
Sponsor
Shahid Beheshti University
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1. Study Identification

Unique Protocol Identification Number
NCT02998931
Brief Title
Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients
Official Title
Effects of Enteral Glutamine on Inflammatory Response, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
August 25, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Enteral Nutrition, Multiple Organ Failure, Infection Complication, Inflammation
Keywords
Glutamin, Enteral Nutrition, Intensive Care Unit, Critical Care Outcomes, inflammatory, Immune System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glutamin
Arm Type
Experimental
Arm Description
Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.
Arm Title
maltodextrin
Arm Type
Placebo Comparator
Arm Description
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
Intervention Type
Drug
Intervention Name(s)
Glutamin
Other Intervention Name(s)
L-glutamine
Intervention Description
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs
Intervention Type
Other
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin mixed with water given via NG tube Q 4 hours
Primary Outcome Measure Information:
Title
Occurrence of infection
Description
Incidence of infections
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Serum Inflammatory Markers
Description
Inflammatory factors
Time Frame
baseline, Day 5, Day 10
Title
Serum Immunity Markers
Time Frame
baseline, Day 5, Day 10
Title
Length of stay in ICU
Time Frame
Day 28
Title
28-day Mortality
Description
Day 28
Time Frame
Day 28
Title
6-month mortality
Description
month 6
Time Frame
month 6
Other Pre-specified Outcome Measures:
Title
Serum Glutamin
Time Frame
baseline, Day 5, Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahra Vahdat Shariatpanahi, MD, PhD
Organizational Affiliation
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Shohada Tajrish Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25096691
Citation
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.
Results Reference
background
PubMed Identifier
23594003
Citation
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.
Results Reference
background
PubMed Identifier
26773077
Citation
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.
Results Reference
background
PubMed Identifier
16697087
Citation
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.
Results Reference
background
PubMed Identifier
18165444
Citation
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.
Results Reference
background
PubMed Identifier
12923621
Citation
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.
Results Reference
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Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

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