NCT02998931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

December 14, 2016

Last Update Submit

October 13, 2018

Conditions

Critical IllnessEnteral NutritionMultiple Organ FailureInfection ComplicationInflammation

Keywords

GlutaminEnteral NutritionIntensive Care UnitCritical Care OutcomesinflammatoryImmune System

Outcome Measures

Primary Outcomes (1)

  • Occurrence of infection

    Incidence of infections

    Day 28

Secondary Outcomes (5)

  • Serum Inflammatory Markers

    baseline, Day 5, Day 10

  • Serum Immunity Markers

    baseline, Day 5, Day 10

  • Length of stay in ICU

    Day 28

  • 28-day Mortality

    Day 28

  • 6-month mortality

    month 6

Other Outcomes (1)

  • Serum Glutamin

    baseline, Day 5, Day 10

Study Arms (2)

Glutamin

EXPERIMENTAL

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

Drug: Glutamin

maltodextrin

PLACEBO COMPARATOR

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

Other: Maltodextrin

Interventions

GlutaminDRUG

Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs

Also known as: L-glutamine
Glutamin
MaltodextrinOTHER

Maltodextrin mixed with water given via NG tube Q 4 hours

maltodextrin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences

Tehran, Iran

Location

Shohada Tajrish Hospital

Tehran, Iran

Location

Related Publications (6)

  • 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.

    PMID: 25096691BACKGROUND

  • 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.

    PMID: 23594003BACKGROUND

  • 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.

    PMID: 26773077BACKGROUND

  • 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.

    PMID: 16697087BACKGROUND

  • 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.

    PMID: 18165444BACKGROUND

  • 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.

    PMID: 12923621BACKGROUND

MeSH Terms

Conditions

Critical IllnessMultiple Organ FailureInflammation

Interventions

glutamin-(asparagin-)aseGlutaminemaltodextrin

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Zahra Vahdat Shariatpanahi, MD, PhD

    Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 21, 2016

Study Start

November 10, 2016

Primary Completion

August 25, 2018

Study Completion

September 10, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

IR(2)