Hypocaloric Enteral Nutrition in the Critically Ill Patient (hipoentnut)

Lafrancol

Status and phase: Completed; Phase 3

Conditions: Critically Ill

Treatments: Dietary Supplement: Normocaloric enteral nutrition; Dietary Supplement: Hipocaloric enteral nutrition

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02577211

hnrct2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Hipocaloric enteral nutrition

Experimental group

Description:

15 kcal per kg of body weight and 1.7 grams of protein per kg.

Treatment:

Dietary Supplement: Hipocaloric enteral nutrition

Normocaloric enteral nutrition

Active Comparator group

Description:

25 kcal per kg of body weight and 1.7 grams of protein per kg.

Treatment:

Dietary Supplement: Normocaloric enteral nutrition