Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Sponsor

Shahid Beheshti University (Other)

Overall Status

Completed

CT.gov ID

NCT02998931

Collaborator

(none)

200

Enrollment

Locations

Arms

Actual Duration (Months)

100

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Enteral Nutrition Multiple Organ Failure Infection Complication Inflammation	Drug: Glutamin Other: Maltodextrin	Phase 3

Detailed Description

A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 200 eligible hospitalized patients with enteral feeding in ICU, aged ≥ 18 years. Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral formula for 28 days and control patients will be received maltodextrin along with enteral formula for 28 days. Patients will be evaluated for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Enteral Glutamine on Inflammatory Response, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit

Actual Study Start Date :

Nov 10, 2016

Actual Primary Completion Date :

Aug 25, 2018

Actual Study Completion Date :

Sep 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glutamin Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.	Drug: Glutamin Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs Other Names: L-glutamine
Placebo Comparator: maltodextrin Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.	Other: Maltodextrin Maltodextrin mixed with water given via NG tube Q 4 hours

Arm

Intervention/Treatment

Experimental: Glutamin

Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.

Drug: Glutamin

Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs

Other Names:

L-glutamine

Placebo Comparator: maltodextrin

Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

Other: Maltodextrin

Maltodextrin mixed with water given via NG tube Q 4 hours

Outcome Measures

Primary Outcome Measures

Occurrence of infection [Day 28]
Incidence of infections

Secondary Outcome Measures

Serum Inflammatory Markers [baseline, Day 5, Day 10]
Inflammatory factors
Serum Immunity Markers [baseline, Day 5, Day 10]
Length of stay in ICU [Day 28]
28-day Mortality [Day 28]
Day 28
6-month mortality [month 6]
month 6

Other Outcome Measures

Serum Glutamin [baseline, Day 5, Day 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences	Tehran		Iran, Islamic Republic of
2	Shohada Tajrish Hospital	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University

Investigators

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