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

Critically Ill Clinical Trial

— GLINT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01240291
• Other study ID #: HREC/10/QRBW/131
• Status: Recruiting
• Phase: Phase 3
• First received: November 1, 2010
• Last updated: May 22, 2012
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: May 2012
• Source: Royal Brisbane and Women's Hospital
• Contact: Ruqaiya M Al-Balushi, MSc
• Phone: + 61 7 3346 5105
• Email: ruqaiya.albalushi[@]uqconnect.edu.au
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Multiple Trauma
• Wounds and Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
Australia	Royal Brisbane & Women's Hospital	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brisbane and Women's Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	Number of infections that are documented during intensive care unit stay.		During intensive care unit stay.	No
Secondary	Number of deaths occuring on or before day 60.		within 60 days.	No
Secondary	Length of stay in intensive care unit.		At discharge from intensive care unit.	No
Secondary	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.	No
Secondary	Number of days on mechanical ventilation.		during intensive care unit stay.	No
Secondary	Number of days of antibiotic use during intensive care unit stay.		during intensive care unit stay.	No
Secondary	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.	No