Hypocaloric Nutrition in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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
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Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial

Conditions
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Critically Ill

Intervention / Treatment
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* Dietary Supplement: Hypocaloric hyperproteic nutrition
* Dietary Supplement: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years estimated fasting period of at least 96 hours Exclusion Criteria: parenteral nutrition pregnancy diabetes liver or renal failure transplantation admitted from another hospital

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>Patients will receive normal nutritional regime of around 25 kcal per kg. | Dietary Supplement: Standard care<br>* 25 kcal per kg of body weight<br>* Other names: Isocaloric;|
| Experimental: Hypocaloric hyperproteic nutrition<br>15 kcal per kg of body weight and 1.7 grams of protein per kg | Dietary Supplement: Hypocaloric hyperproteic nutrition<br>* 15 kcal per kg of body weight and 1.7 grams of protein per kg.<br>* Other names: Hypocaloric hyperproteic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adults