Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Shahid Beheshti University

Status and phase: Completed; Phase 3

Conditions: Multiple Organ Failure; Inflammation; Enteral Nutrition; Critical Illness; Infection Complication

Treatments: Drug: Glutamin; Other: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT02998931

1395/670

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Glutamin

Experimental group

Description:

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

Treatment:

Drug: Glutamin

maltodextrin

Placebo Comparator group

Description:

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

Treatment:

Other: Maltodextrin