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| Name | Class |
|---|---|
| Hospital Universitario San Ignacio | 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). 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 |
|---|---|---|---|
| Standard care | Active Comparator | Patients will receive normal nutritional regime of around 25 kcal per kg. |
|
| Hypocaloric hyperproteic nutrition | Experimental | 15 kcal per kg of body weight and 1.7 grams of protein per kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypocaloric hyperproteic nutrition | Dietary Supplement | 15 kcal per kg of body weight and 1.7 grams of protein per kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SOFA (Sequential Organ Failure Assessment) Score | 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 since nutritional regime starts |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Requirements | This is an indirect measure of glycemic control, and is reported as a daily average. | Daily until day 21 or discharge from ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saul Rugeles, MD | Pontificia Universidad Javeriana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario San Ignacio | Bogotá | DC | 110311 | Colombia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Patients will receive normal nutritional regime of around 25 kcal per kg. Standard care: 25 kcal per kg of body weight |
| FG001 | Hypocaloric Hyperproteic Nutrition | 15 kcal per kg of body weight and 1.7 grams of protein per kg Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Patients will receive normal nutritional regime of around 25 kcal per kg. Standard care: 25 kcal per kg of body weight |
| BG001 | Hypocaloric Hyperproteic Nutrition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SOFA (Sequential Organ Failure Assessment) Score | 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). | Posted | Mean | Standard Deviation | units on a scale | 48 hours since nutritional regime starts |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Patients will receive normal nutritional regime of around 25 kcal per kg. Standard care: 25 kcal per kg of body weight |
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No surgical patients included Wide variety of patients Caloric needs were not estimated with a gold standard
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Saul Rugeles | Pontificia Universidad Javeriana | 5715946161 | 2240 | rujeles@javeriana.edu.co |
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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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Dietary Supplement | 25 kcal per kg of body weight |
|
|
15 kcal per kg of body weight and 1.7 grams of protein per kg
Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Insulin Requirements | This is an indirect measure of glycemic control, and is reported as a daily average. | Posted | Mean | Standard Deviation | International Unit of insulin | Daily until day 21 or discharge from ICU |
|
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|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Hypocaloric Hyperproteic Nutrition | 15 kcal per kg of body weight and 1.7 grams of protein per kg Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg. | 0 | 40 | 0 | 40 |
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