The Clinical Role of Intravenous Glutamine in Trauma Patients Receiving Enteral Nutrition (GLINT)

This study is currently recruiting participants.
Verified May 2012 by Royal Brisbane and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Ruqaiya Al-Balushi, Royal Brisbane and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01240291
First received: November 1, 2010
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

The purpose of this trial is to investigate if pharmacologically safe dose intravenous glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications, and other secondary outcomes


Condition Intervention Phase
Multiple Trauma
Critically Ill
Dietary Supplement: Dipeptiven
Dietary Supplement: normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intravenous GLutamine Supplementation IN Trauma Patients Receiving Enteral Nutrition Study Protocol (GLINT Study): A Prospective, Blinded, Randomized, Placebo-controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Royal Brisbane and Women's Hospital:

Primary Outcome Measures:
  • The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days. [ Time Frame: daily until discharge from intensive care unit, death or maximum duration of 10 days. ] [ Designated as safety issue: No ]
    The change in daily total SOFA score plotted each day over 10 days, where we will compare the regression slope between the two arms of the study.


Secondary Outcome Measures:
  • The change in daily total Sequential Organ failure Assessment Score (SOFA) on the last day of treatment as a measure of severity of organ dysfunction. [ Time Frame: Last day of treatment ] [ Designated as safety issue: No ]
  • Number of infections that are documented during intensive care unit stay. [ Time Frame: During intensive care unit stay. ] [ Designated as safety issue: No ]
  • Number of deaths occuring on or before day 60. [ Time Frame: within 60 days. ] [ Designated as safety issue: No ]
  • Length of stay in intensive care unit. [ Time Frame: At discharge from intensive care unit. ] [ Designated as safety issue: No ]
  • Length of stay in hospital. [ Time Frame: At hospital discharge. ] [ Designated as safety issue: No ]
    Length of stay in hospital (if delayed discharge due to placement problems, will record from the date the patient is regarded as fit for discharge by medical staff).

  • Number of days on mechanical ventilation. [ Time Frame: during intensive care unit stay. ] [ Designated as safety issue: No ]
  • Number of days of antibiotic use during intensive care unit stay. [ Time Frame: during intensive care unit stay. ] [ Designated as safety issue: No ]
  • Fat free mass and fat percentage as a measure of body composition by Bioelectric Impedance analysis (BIA). [ Time Frame: every 2 days until discharge from the intensive care unit. ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alanyl-glutamine
Intravenous alanyl-glutamine (0.5 g/kg body weight/day)
Dietary Supplement: Dipeptiven
Intravenous alanyl-glutamine (0.5 g/kg body weight; i.e. 0.35 g L-glutamine / kg body weight; continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks.
Other Names:
  • Dipeptiven
  • Fresenius Kabi
Placebo Comparator: normal saline
Intravenous placebo (normal saline; 0.9 %)
Dietary Supplement: normal saline
0.5 g/kg bod weight /day, continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks
Other Name: NaCl

Detailed Description:

Trauma Patients are characterized by alteration in the immune response, increased exposure to infectious complications, sepsis, and consequently organ failure and death. Glutamine supplementation to parenteral nutrition is one of the nutritional interventions that have been proven to be associated with improved survival rate, decreased infectious morbidity, costs, intensive care unit, and hospital length of stay. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. A number of trials investigated the beneficial effects of intravenous alanyl-glutamine supplementation in critically ill patients receiving enteral nutrition. However, these trials were: pilot trials, investigated surrogate outcomes, or supplementation was for a short period of time. Therefore, a well designed trial is needed to investigate the effect of intravenous alanyl-glutamine supplementation in critically ill patients with multiple trauma receiving enteral nutrition on major clinical outcomes.

Our hypothesis is that trauma patients receiving standard enteral nutrition supplemented with intravenous alanyl-glutamine will demonstrate improved clinical outcomes compared to patients receiving standard enteral nutrition without supplementation.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-58 years
  • Patients admitted with a diagnosis of multiple trauma requiring enteral feeding for > 48 hours
  • Expected length of stay in ICU > 48 hours
  • Has a functional access for enteral tube feeding and a central access for administration of test solution
  • Negative Beta HCG (pregnancy test) in females (18-60 years)

Exclusion Criteria:

  • Age < 18 years
  • Significant hepatic failure (Patients with Childs C Cirrhosis)
  • Severe renal failure (estimated glomerular filtration rate [eGFR] < 50 ml/min)
  • Patients with severe metabolic acidosis (pH <7.35)
  • Not expected to be in the ICU > 48 hours (due to imminent death)
  • Unable to tolerate enteral nutrition within 72 hours
  • Enrolment in other ICU intervention study if contraindicated
  • Patients in whom parenteral nutrition is required from the outset
  • Absolute contraindication to enteral nutrition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240291

Contacts
Contact: Ruqaiya M Al-Balushi, MSc + 61 7 3346 5105 ruqaiya.albalushi@uqconnect.edu.au
Contact: Jennifer Paratz, PhD + 61 7 36361980 j.paratz@uq.edu.au

Locations
Australia, Queensland
Royal Brisbane & Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Sponsors and Collaborators
Royal Brisbane and Women's Hospital
Investigators
Principal Investigator: Jeffrey Lipman, MBBCh, MD Royal Brisbane & Women's Hpsoital
  More Information

No publications provided

Responsible Party: Ruqaiya Al-Balushi, Researcher, Royal Brisbane and Women's Hospital
ClinicalTrials.gov Identifier: NCT01240291     History of Changes
Other Study ID Numbers: HREC/10/QRBW/131
Study First Received: November 1, 2010
Last Updated: May 22, 2012
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Royal Brisbane and Women's Hospital:
glutamine
trauma
alanyl-glutamine

Additional relevant MeSH terms:
Critical Illness
Multiple Trauma
Wounds and Injuries
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014