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

Phase 3

• Conditions: Multiple Trauma; Critically Ill
• Interventions: Dietary Supplement: Dipeptiven; Dietary Supplement: normal saline

• Registration Number: NCT01240291
• Lead Sponsor: Royal Brisbane and Women's Hospital

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

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 Timeline

• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-15
• Study Start: 2011-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-22
• Last Update Posted: 2012-05-24
• Primary Completion: 2012-12
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alanyl-glutamine	Dipeptiven	Intravenous alanyl-glutamine (0.5 g/kg body weight/day)
normal saline	normal saline	Intravenous placebo (normal saline; 0.9 %)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	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.	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.

Trial Locations

Locations (1)

Royal Brisbane & Women's Hospital; 🇦🇺 Brisbane, Queensland, Australia