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

NCT01240291 | Unknown Phase 3

• 1 other identifier: HREC/10/QRBW/131
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Trauma; Critically Ill

Keywords

glutamine; trauma; alanyl-glutamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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.

  At hospital discharge.

Study Arms (2)

alanyl-glutamine

EXPERIMENTAL

Intravenous alanyl-glutamine (0.5 g/kg body weight/day)

Dietary Supplement: Dipeptiven

normal saline

PLACEBO COMPARATOR

Intravenous placebo (normal saline; 0.9 %)

Dietary Supplement: normal saline

Interventions

Dipeptiven DIETARY_SUPPLEMENT

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.

Also known as: Fresenius Kabi

alanyl-glutamine

normal saline DIETARY_SUPPLEMENT

0.5 g/kg bod weight /day, continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks

Also known as: NaCl

normal saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brisbane and Women's Hospital: lead

Study Sites (1)

Royal Brisbane & Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

Related Publications (1)

• 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.

  PMID: 22102646 DERIVED

MeSH Terms

Conditions

Multiple Trauma; Critical Illness; Wounds and Injuries

Interventions

alanylglutamine; Saline Solution

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jeffrey Lipman, MBBCh, MD

  Royal Brisbane & Women's Hpsoital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruqaiya M Al-Balushi, MSc

CONTACT

+ 61 7 3346 5105; ruqaiya.albalushi@uqconnect.edu.au

Jennifer Paratz, PhD

CONTACT

+ 61 7 36361980; j.paratz@uq.edu.au

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 GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 15, 2010
• Study Start: March 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: May 24, 2012

Record last verified: 2012-05

Locations

AU (1)