Hypocaloric Enteral Nutrition in the Critically Ill Patient

NCT ID: NCT02577211

Last Updated: 2015-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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

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Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Hipocaloric enteral nutrition

15 kcal per kg of body weight and 1.7 grams of protein per kg.

Group Type EXPERIMENTAL

Hipocaloric enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

15 kcal/Kg of body weight

Normocaloric enteral nutrition

25 kcal per kg of body weight and 1.7 grams of protein per kg.

Group Type ACTIVE_COMPARATOR

Normocaloric enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

25 kcal/kg of body weight

Interventions

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Hipocaloric enteral nutrition

15 kcal/Kg of body weight

Intervention Type DIETARY_SUPPLEMENT

Normocaloric enteral nutrition

25 kcal/kg of body weight

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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low caloric delivery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario San Ignacio

OTHER

Sponsor Role collaborator

Pontificia Universidad Javeriana

OTHER

Sponsor Role collaborator

Lafrancol S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saul J Rugeles, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario San Ignacio

Locations

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Hospital Universitario San Ignacio

Bogotá, Bogota D.C., Colombia

Site Status

Countries

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Colombia

Other Identifiers

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hnrct2

Identifier Type: -

Identifier Source: org_study_id

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