Hypocaloric Enteral Nutrition in the Critically Ill Patient (hipoentnut)

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

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill
• Intervention / Treatment: Dietary supplement: Hipocaloric enteral nutrition; Dietary supplement: Normocaloric enteral nutrition

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Bogota, Colombia, 000000
    • Hospital Universitario San Ignacio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hipocaloric enteral nutrition; 15 kcal per kg of body weight and 1.7 grams of protein per kg.	Dietary supplement: Hipocaloric enteral nutrition; 15 kcal/Kg of body weight; Other Names: low caloric delivery
ACTIVE_COMPARATOR: Normocaloric enteral nutrition; 25 kcal per kg of body weight and 1.7 grams of protein per kg.	Dietary supplement: Normocaloric enteral nutrition; 25 kcal/kg of body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.	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 after the onset of nutrition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Units of insulin require in a day	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.	Within the first 4 days after the onset of nutrition
Number of days the patient requires mechanical ventilation.	Measure daily	Within the first 28 days after the onset of nutrition
Number of days in the intensive care unit	Measure daily	Within the first 28 days after the onset of nutrition
Mortality to 28 days	We will interview each patient 28 days after the start of the study to assess the global mortality	28 days after the onset of nutrition

Collaborators and Investigators

• Sponsor: Lafrancol S.A.
• Collaborators: Hospital Universitario San Ignacio; Pontificia Universidad Javeriana
• Investigators: Principal Investigator: Saul J Rugeles, MD, Hospital Universitario San Ignacio

Publications and helpful links

Helpful Links

• Webpage of the surgery department

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: October 10, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (ESTIMATE): October 16, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 7, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Critically ill; Enteral nutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: hnrct2