Critical Illness, Enteral Nutrition, Infection Complication, Inflammation, Multiple Organ Failure
Conditions
Keywords
Glutamin, Enteral Nutrition, Intensive Care Unit, Critical Care Outcomes, inflammatory, Immune System
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.
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.
Interventions
DRUGGlutamin
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs
OTHERMaltodextrin
Maltodextrin mixed with water given via NG tube Q 4 hours
Sponsors
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of infection | Day 28 | Incidence of infections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Inflammatory Markers | baseline, Day 5, Day 10 | Inflammatory factors |
| Serum Immunity Markers | baseline, Day 5, Day 10 | — |
| 28-day Mortality | Day 28 | Day 28 |
| 6-month mortality | month 6 | month 6 |
| Length of stay in ICU | Day 28 | — |
Other
| Measure | Time frame |
|---|---|
| Serum Glutamin | baseline, Day 5, Day 10 |
Countries
Iran
Outcome results
None listed