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

Royal Brisbane and Women's Hospital

Status and phase: Unknown; Phase 3

Conditions: Critically Ill; Multiple Trauma

Treatments: Dietary Supplement: Dipeptiven; Dietary Supplement: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01240291

HREC/10/QRBW/131

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

alanyl-glutamine

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dipeptiven

normal saline

Placebo Comparator group

Description:

Intravenous placebo (normal saline; 0.9 %)

Treatment:

Dietary Supplement: normal saline