Hypocaloric Nutrition in Critically Ill Patients

Phase 3

Completed

• Conditions: Critically Ill
• Interventions: Dietary Supplement: Standard care; Dietary Supplement: Hypocaloric hyperproteic nutrition

• Registration Number: NCT01531335
• 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). 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: 2011-08
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-10
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2013-12-16
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-07
• Last Update Submitted: 2015-11-07
• Results First Posted: 2015-12-11
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Patients will receive normal nutritional regime of around 25 kcal per kg.
Hypocaloric hyperproteic nutrition	Hypocaloric hyperproteic nutrition	15 kcal per kg of body weight and 1.7 grams of protein per kg

Primary Outcome Measures

Name	Time	Method
SOFA (Sequential Organ Failure Assessment) Score	48 hours since nutritional regime starts	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
Insulin Requirements	Daily until day 21 or discharge from ICU	This is an indirect measure of glycemic control, and is reported as a daily average.

Trial Locations

Locations (1)

Hospital Universitario San Ignacio; 🇨🇴 Bogota, DC, Colombia