Overview

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