Hypocaloric Enteral Nutrition in the Critically Ill Patient

Phase 3

Completed

• Conditions: Critically Ill
• Interventions: Dietary Supplement: Normocaloric enteral nutrition; Dietary Supplement: Hipocaloric enteral nutrition

• Registration Number: NCT02577211
• Lead Sponsor: Lafrancol S.A.

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2015-10-10
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-16
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-07
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normocaloric enteral nutrition	Normocaloric enteral nutrition	25 kcal per kg of body weight and 1.7 grams of protein per kg.
Hipocaloric enteral nutrition	Hipocaloric enteral nutrition	15 kcal per kg of body weight and 1.7 grams of protein per kg.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Hospital Universitario San Ignacio; 🇨🇴 Bogota, Colombia