Hypocaloric Enteral Nutrition in the Critically Ill Patient

Critically Ill Clinical Trial

— hipoentnut  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577211
• Other study ID #: hnrct2
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2015
• Last updated: November 7, 2015
• Start date: December 2013
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Lafrancol S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Oficina de investigación Hospital Universitario San Ignacio
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Dietary Supplement:
• Hipocaloric enteral nutrition
15 kcal/Kg of body weight
• Normocaloric enteral nutrition
25 kcal/kg of body weight

Locations

Country	Name	City	State
Colombia	Hospital Universitario San Ignacio	Bogota

Sponsors (3)

Lead Sponsor	Collaborator
Lafrancol S.A.	Hospital Universitario San Ignacio, Pontificia Universidad Javeriana

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Number of days the patient requires mechanical ventilation.	Measure daily	Within the first 28 days after the onset of nutrition	No
Secondary	Number of days in the intensive care unit	Measure daily	Within the first 28 days after the onset of nutrition	No
Secondary	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	No

External Links

•   Webpage of the surgery department