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| Name | Class |
|---|---|
| Isfahan University of Medical Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine 0.5 g/kg/day | Active Comparator |
| |
| Glutamine 1 g/kg/day | Active Comparator |
| |
| Enteral Nutrition | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine 0.5 g/kg/day | Dietary Supplement | Glutamine 0.5 g/kg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Probability Score | Infection Probability Score will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention |
| Systemic Inflammatory Response Syndrome | Systemic Inflammatory Response Syndrome will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Prealbumin | Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention |
| CRP | CRP will be measured and will be compared to the baseline after 10 days of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Zahra Hospital | Isfahan | Isfahan | Iran |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Glutamine 1 g/kg/day |
| Dietary Supplement |
Glutamine 1 g/kg/day |
|
| Enteral Nutrition | Dietary Supplement | Ordinary Enteral Nutrition |
|
| 10 days after intervention |
| Serum prealbumin | Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after the intervention |
| Length of stay (LOS) | LOS will be measured and will be compared to the baseline after 10 days of the intervention |
| Bed sores | Bed sores will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention |
| Mechanical ventilation | Mean mechanical ventilation need will be measured and will be compared to the baseline after 10 days of the intervention | 10 days after intervention |
| D021542 | Amino Acids, Neutral |
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |