Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

• Status: Completed
• Trial end date: 2018-09-10
• Target enrollment: 0
• Participant gender: All

Summary

Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill patients, possibly in part through an attenuation of the proinflammatory cytokine response and a Immune function. In this trial intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 28 days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shahid Beheshti University

Criteria

Inclusion Criteria:

• Adult patients (>18 years old) admitted to ICU

• Start of study intervention within 48 hours after ICU admission

• Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour

• Written informed consent of patient or written informed consent of legal representative

Exclusion Criteria:

• Enrollment in a related ICU interventional study

• Requiring other specific enteral nutrition for medical reason

• Death or Discharge before 5th day

• Having any contra-indication to receive enteral nutrition

• Pregnant patients or lactating with the intent to breastfeed

• Requiring other specific enteral nutrition for medical reason

• BMI <18 or > 40.0 kg/m2

• Have life expectancy of <6 mo

• Patients who are moribond

• Liver cirrhosis- Child's class C liver disease

• Have seizure disorder requiring anticonvulsant

• History of allergy or intolerance to the study product components

• Receiving glutamine during two weeks before start study product

• Have other reasons