NCT02577211

Hypocaloric Enteral Nutrition in the Critically Ill Patient

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Lafrancol S.A. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critically Ill

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hipocaloric enteral nutrition	15 kcal/Kg of body weight
DIETARY_SUPPLEMENT	Normocaloric enteral nutrition	25 kcal/kg of body weight

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-10-16
• Last updated: 2015-11-10

Locations

1 site across 1 country: Colombia