Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02998931
• Date of registration: 14/12/2016
• Prospective Registration: No
• Primary sponsor: Shahid Beheshti University
• Public title: Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients
• Scientific title: Effects of Enteral Glutamine on Inflammatory Response, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
• Date of first enrolment: November 10, 2016
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02998931
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Iran, Islamic Republic of

Contacts

• Name: Zahra Vahdat Shariatpanahi, MD, PhD
• Affiliation: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Organ Failure

Critical Illness

Enteral Nutrition

Infection Complication

Inflammation

Intervention(s)

Other: Maltodextrin

Drug: Glutamin

Primary Outcome(s)

Occurrence of infection [Time Frame: Day 28]

Secondary Outcome(s)

28-day Mortality [Time Frame: Day 28]

6-month mortality [Time Frame: month 6]

Length of stay in ICU [Time Frame: Day 28]

Serum Immunity Markers [Time Frame: baseline, Day 5, Day 10]

Serum Inflammatory Markers [Time Frame: baseline, Day 5, Day 10]

Secondary ID(s)

1395/670

Source(s) of Monetary Support

Please refer to primary and secondary sponsors