Trauma Patients in ICU
Conditions
Brief summary
This is a double-blinded placebo-controlled block randomized study in intensive care patients comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS) and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum inflammatory mediators will be compared.
Interventions
DIETARY_SUPPLEMENTGlutamine 0.5 g/kg/day
Glutamine 0.5 g/kg/day
DIETARY_SUPPLEMENTGlutamine 1 g/kg/day
Glutamine 1 g/kg/day
DIETARY_SUPPLEMENTEnteral Nutrition
Ordinary Enteral Nutrition
Sponsors
Isfahan University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60 * No corticosteroids use * No history of heart, liver and kidney diseases * Nutrition through nasogastric or orogastric
Exclusion criteria
* Patients who will not tolerate enteral nutrition for more than 48 hours * Patients who are NPO and nutritional support has not started * Lactating and pregnant women * Kidney failure during the study * A history of glutamin supplement use before the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection Probability Score | 10 days after intervention | Infection Probability Score will be measured and will be compared to the baseline after 10 days of the intervention |
| Systemic Inflammatory Response Syndrome | 10 days after intervention | Systemic Inflammatory Response Syndrome will be measured and will be compared to the baseline after 10 days of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRP | 10 days after intervention | CRP will be measured and will be compared to the baseline after 10 days of the intervention |
| Serum prealbumin | 10 days after the intervention | Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention |
| Mechanical ventilation | 10 days after intervention | Mean mechanical ventilation need will be measured and will be compared to the baseline after 10 days of the intervention |
| Bed sores | 10 days after intervention | Bed sores will be measured and will be compared to the baseline after 10 days of the intervention |
| Length of stay (LOS) | — | LOS will be measured and will be compared to the baseline after 10 days of the intervention |
| Prealbumin | 10 days after intervention | Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention |
Countries
Iran
Outcome results
None listed