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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Multiple Trauma Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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alanyl-glutamine

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

Group Type EXPERIMENTAL

Dipeptiven

Intervention Type 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.

normal saline

Intravenous placebo (normal saline; 0.9 %)

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fresenius Kabi NaCl

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No