Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients
- Conditions
- Critical IllnessEnteral NutritionIntestinal Permeability
- Interventions
- Drug: GlutaminOther: Maltodextrin
- Registration Number
- NCT03113240
- Lead Sponsor
- Shahid Beheshti University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glutamin Glutamin Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs. maltodextrin Maltodextrin Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
- Primary Outcome Measures
Name Time Method Maximum plasma endotoxin concentration baseline, Day 5, Day 10 The levels of plasma endotoxin
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 zonulin concentration baseline, Day 5, Day 10 The levels of plasma zonulin
- Secondary Outcome Measures
Name Time Method Mortality in ICU Day 10 Mortality rate in ICU
Length of stay in ICU Day 10 Duration of stay in ICU
Gastrointestinal complication Day10 abdominal distention, vomiting, diarrhea and constipation
Severe sepsis Day 10 according to the American College of Chest Physicians and the Society of Critical Care Medicine
Trial Locations
- Locations (1)
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital
🇮🇷Tehran, Iran, Islamic Republic of