Critically Ill
Conditions
Keywords
Critically ill, Enteral nutrition
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTHipocaloric enteral nutrition
15 kcal/Kg of body weight
DIETARY_SUPPLEMENTNormocaloric enteral nutrition
25 kcal/kg of body weight
Sponsors
Hospital Universitario San Ignacio
Pontificia Universidad Javeriana
Lafrancol S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* \>18 years * Estimated fasting period of at least 96 hours * ICU patients
Exclusion criteria
* Parenteral nutrition * Pregnancy * Diabetes * Liver failure * Transplantation or in transplant protocol * Previous nutrition support * Chronic Renal failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours. | 48 hours after the onset of nutrition | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Units of insulin require in a day | Within the first 4 days after the onset of nutrition | 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. |
| Number of days the patient requires mechanical ventilation. | Within the first 28 days after the onset of nutrition | Measure daily |
| Number of days in the intensive care unit | Within the first 28 days after the onset of nutrition | Measure daily |
| Mortality to 28 days | 28 days after the onset of nutrition | We will interview each patient 28 days after the start of the study to assess the global mortality |
Countries
Colombia
Outcome results
None listed