Hypocaloric Enteral Nutrition in the Critically Ill Patient

Study Overview
=================
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.

Official Title
-----------------
Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Dietary Supplement: Hipocaloric enteral nutrition
* Dietary Supplement: Normocaloric enteral nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hipocaloric enteral nutrition<br>15 kcal per kg of body weight and 1.7 grams of protein per kg. | Dietary Supplement: Hipocaloric enteral nutrition<br>* 15 kcal/Kg of body weight<br>* Other names: low caloric delivery;|
| Active Comparator: Normocaloric enteral nutrition<br>25 kcal per kg of body weight and 1.7 grams of protein per kg. | Dietary Supplement: Normocaloric enteral nutrition<br>* 25 kcal/kg of body weight<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critically ill, Enteral nutrition