Critical Illness, Enteral Nutrition, Intestinal Permeability
Conditions
Keywords
Glutamin, Enteral Nutrition, Intensive Care Unit, Intestinal Permeability
Brief summary
Glutamine-induced recovery in intestinal barrier function by reducing bacterial translocation was demonstrated in previous studies. In this trial, intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 10 days and the effects of the intervention on intestinal permeability will be assessed.
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 60 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 10days and control patients will be received maltodextrin along with enteral formula for 10 days. Patients will be evaluated for plasma endotoxin and plasma zonulin.
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 * 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 |
|---|---|---|
| Maximum plasma antiendotoxin IgG and Ig M concentration | baseline, Day 5, Day 10 | The levels of plasma antiendotoxin IgG and Ig M concentration |
| Maximum plasma endotoxin concentration | baseline, Day 5, Day 10 | The levels of plasma endotoxin |
| Maximum plasma zonulin concentration | baseline, Day 5, Day 10 | The levels of plasma zonulin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in ICU | Day 10 | Duration of stay in ICU |
| Severe sepsis | Day 10 | according to the American College of Chest Physicians and the Society of Critical Care Medicine |
| Gastrointestinal complication | Day10 | abdominal distention, vomiting, diarrhea and constipation |
| Mortality in ICU | Day 10 | Mortality rate in ICU |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum Glutamin | baseline, Day 5, Day 10 | The levels of serum Glutamin |
Countries
Iran
Outcome results
None listed