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| Name | Class |
|---|---|
| Hospital Universitario San Ignacio | OTHER |
| Pontificia Universidad Javeriana | OTHER |
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The aim of this study is to compare two nutritional regimes in critically ill patients. Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.
The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will >18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others.
The SOFA score will be assessed every two days until discharge from ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hipocaloric enteral nutrition | Experimental | 15 kcal per kg of body weight and 1.7 grams of protein per kg. |
|
| Normocaloric enteral nutrition | Active Comparator | 25 kcal per kg of body weight and 1.7 grams of protein per kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hipocaloric enteral nutrition | Dietary Supplement | 15 kcal/Kg of body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours. | SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality). | 48 hours after the onset of nutrition |
| Measure | Description | Time Frame |
|---|---|---|
| Units of insulin require in a day | This is an indirect measure of glycemic control, and is reported as a daily average of the units of insuline require in the first 4 days since nutritional regimen starts. | Within the first 4 days after the onset of nutrition |
| Number of days the patient requires mechanical ventilation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saul J Rugeles, MD | Hospital Universitario San Ignacio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario San Ignacio | Bogotá | Bogota D.C. | 000000 | Colombia |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Normocaloric enteral nutrition | Dietary Supplement | 25 kcal/kg of body weight |
|
Measure daily |
| Within the first 28 days after the onset of nutrition |
| Number of days in the intensive care unit | Measure daily | Within the first 28 days after the onset of nutrition |
| Mortality to 28 days | We will interview each patient 28 days after the start of the study to assess the global mortality | 28 days after the onset of nutrition |