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

Effect of Intravenous GLutamine Supplementation IN Trauma Patients Receiving Enteral Nutrition Study Protocol (GLINT Study): A Prospective, Blinded, Randomized, Placebo-controlled Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: Multiple Trauma; Critically Ill
• Intervention / Treatment: Dietary supplement: Dipeptiven; Dietary supplement: normal saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4029
      • Recruiting
      • Royal Brisbane & Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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 Names: NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days.	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.	daily until discharge from intensive care unit, death or maximum duration of 10 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.		Last day of treatment
Number of infections that are documented during intensive care unit stay.		During intensive care unit stay.
Number of deaths occuring on or before day 60.		within 60 days.
Length of stay in intensive care unit.		At discharge from intensive care unit.
Length of stay in hospital.	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).	At hospital discharge.
Number of days on mechanical ventilation.		during intensive care unit stay.
Number of days of antibiotic use during intensive care unit stay.		during intensive care unit stay.
Fat free mass and fat percentage as a measure of body composition by Bioelectric Impedance analysis (BIA).		every 2 days until discharge from the intensive care unit.

Collaborators and Investigators

• Sponsor: Royal Brisbane and Women's Hospital
• Investigators: Principal Investigator: Jeffrey Lipman, MBBCh, MD, Royal Brisbane & Women's Hpsoital

Publications and helpful links

General Publications

• Al Balushi RM, Paratz JD, Cohen J, Banks M, Dulhunty J, Roberts JA, Lipman J. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial. BMJ Open. 2011 Nov 14;1(2):e000334. doi: 10.1136/bmjopen-2011-000334. Print 2011.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: November 1, 2010
• First Submitted That Met QC Criteria: November 10, 2010
• First Posted (Estimate): November 15, 2010

Study Record Updates

• Last Update Posted (Estimate): May 24, 2012
• Last Update Submitted That Met QC Criteria: May 22, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: trauma; glutamine; alanyl-glutamine
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Wounds and Injuries; Critical Illness; Multiple Trauma
• Other Study ID Numbers: HREC/10/QRBW/131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No