NCT00133978

Brief Summary

The purpose of this study is to determine whether providing high dose glutamine and antioxidants to critically ill patients will be associated with improved survival.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
5 countries

34 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

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 9, 2014

Completed
Last Updated

January 7, 2021

Status Verified

December 1, 2020

Enrollment Period

6.7 years

First QC Date

August 22, 2005

Results QC Date

April 29, 2013

Last Update Submit

December 11, 2020

Conditions

Critical IllnessSepsisMultiple Organ Failure

Keywords

randomized trialantioxidantsglutamineorgan failure

Outcome Measures

Primary Outcomes (1)

  • 28-day Mortality

    28-day mortality/status: at 28 days after randomization;

    Day 28

Secondary Outcomes (3)

  • ICU Length of Stay

    Day 28

  • ICU Acquired Infection

    Day 28

  • Hospital Length of Stay

    6 months (from ICU admission)

Study Arms (4)

Glutamine

EXPERIMENTAL

Glutamine supplementation

Other: Glutamine

Antioxidants

EXPERIMENTAL

Antioxidant supplementation

Other: Antioxidants

Glutamine + Antioxidants

EXPERIMENTAL

Glutamine and antioxidant supplementation

Other: Glutamine + Antioxidants

Placebo

PLACEBO COMPARATOR

Non-isonitrogenic, iso-caloric placebo solution

Other: Placebo

Interventions

GlutamineOTHER

0.35 gm/kg/day parenterally and 30 gms/day enterally

Glutamine
AntioxidantsOTHER

500 micrograms of selenium/day parenterally and selenium 300 microgram, zinc 20 mg, beta carotene 10 mg, vitamine E 500 mg and vitamin C 1500 mg per day enterally

Antioxidants
Glutamine + AntioxidantsOTHER

0.35 g/kg/day glutamine parenterally and 30 g/day of glutamine enterally. 500 mcg selenium parenterally plus the following administered enterally: selenium 300 mcg, zing 20 mg, beta-carotene 10 mg, vitamin E 500 mg and vitamin C 1500mg

Also known as: Dipeptiven, Microselenium/Selenium injection/selenase, EN REDOX formula (from Fresenius Kabi, Germany)
Glutamine + Antioxidants
PlaceboOTHER

Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)

Placebo

Eligibility Criteria

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

You may qualify if:

  • Mechanically ventilated patients \> or = 18 years old
  • or more organ failures related to acute illness

You may not qualify if:

  • \> 24 hours from admission to ICU
  • Patients who are moribund
  • Lack of commitment to aggressive care
  • Absolute contraindication to enteral nutrients
  • Severe acquired brain injury
  • Routine elective cardiac surgery
  • Primary admission of burns \> 30% body surface area
  • Weight \< 50 kgms or \> 200 kgms
  • Pregnant or lactating patients
  • Previous randomization in this study
  • Enrollment in a related ICU interventional study
  • Child's class C liver disease
  • Metastatic cancer with life expectancy \< 6 months
  • Seizure disorder requiring anticonvulsant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Univ. of Colorado at Denver and Health Sciences Center

Aurora, Colorado, 80045, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

University of Texas

Houston, Texas, 6431, United States

Location

Fletcher Allan Centre

Burlington, Vermont, 05401, United States

Location

UZ Brussels

Brussels, Belgium

Location

University Hospital

Liège, B-4000, Belgium

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Grey Nun's Hospital, Edmonton

Edmonton, Alberta, T6L 5X8, Canada

Location

Vancouver Hospital

Vancouver, British Columbia, V5Z 1C6, Canada

Location

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

Victoria General Hospital

Victoria, British Columbia, V8Z 6R5, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Science Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Capital Health Queen Elizabeth II HSC

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

St Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London HSC Victoria Campus, ON

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8H6, Canada

Location

Ottawa Hospital Civic Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook & Women's College, Toronto

Toronto, Ontario, M4N 3M5, Canada

Location

Mt Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Hopital Maisonneuve-Rosemount

Montreal, Quebec, H1T 2M4, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General

Montreal, Quebec, H3G 1A4, Canada

Location

Hopital de Sacre-Coeur

Montreal, Quebec, H4J 1C5, Canada

Location

Enfant-Jesus

Québec, G1J 1Z4, Canada

Location

Universitatsklinikum der Ernst-Moritz-Arndt-Universitat

Greifswald, Germany

Location

Asklepios Kliniken Hamburg Altona

Hamburg, Germany

Location

University Medical Center Schleswig-Holstein

Kiel, 24105, Germany

Location

Universitatsklinikum Schleswig-Holstein Campus Luebeck

Lübeck, Germany

Location

CHUV

Lausanne, Ch-1011, Switzerland

Location

University of Zurich

Zurich, Switzerland

Location

Related Publications (5)

  • Heyland DK, Dhaliwal R, Drover JW, Gramlich L, Dodek P; Canadian Critical Care Clinical Practice Guidelines Committee. Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients. JPEN J Parenter Enteral Nutr. 2003 Sep-Oct;27(5):355-73. doi: 10.1177/0148607103027005355.

    PMID: 12971736BACKGROUND

  • Heyland DK, Dhaliwal R, Suchner U, Berger MM. Antioxidant nutrients: a systematic review of trace elements and vitamins in the critically ill patient. Intensive Care Med. 2005 Mar;31(3):327-37. doi: 10.1007/s00134-004-2522-z. Epub 2004 Dec 17.

    PMID: 15605227BACKGROUND

  • Novak F, Heyland DK, Avenell A, Drover JW, Su X. Glutamine supplementation in serious illness: a systematic review of the evidence. Crit Care Med. 2002 Sep;30(9):2022-9. doi: 10.1097/00003246-200209000-00011.

    PMID: 12352035BACKGROUND

  • 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: 23594003RESULT

  • Heyland DK, Elke G, Cook D, Berger MM, Wischmeyer PE, Albert M, Muscedere J, Jones G, Day AG; Canadian Critical Care Trials Group. Glutamine and antioxidants in the critically ill patient: a post hoc analysis of a large-scale randomized trial. JPEN J Parenter Enteral Nutr. 2015 May;39(4):401-9. doi: 10.1177/0148607114529994. Epub 2014 May 5.

    PMID: 24803474DERIVED

Related Links

MeSH Terms

Conditions

Critical IllnessSepsisMultiple Organ Failure

Interventions

GlutamineAntioxidantsalanylglutamine

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationShock

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, NeutralBiological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Results Point of Contact

Title
Dr. Daren Heyland
Organization
Clinical Evaluation Research Unit
dkh2@queensu.ca
613-549-6666

Study Officials

  • Daren Heyland, MD

    Clinical Evaluation Research Unit, Kingston General Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

April 1, 2005

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

January 7, 2021

Results First Posted

September 9, 2014

Record last verified: 2020-12

Locations

DE(4)US(5)CH(2)BE(2)CA(21)