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Hypocaloric Nutrition in Critically Ill Patients

NCT ID: NCT01531335

Last Updated: 2015-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-08-31

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). 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

Keywords

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adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard care

Patients will receive normal nutritional regime of around 25 kcal per kg.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type DIETARY_SUPPLEMENT

25 kcal per kg of body weight

Hypocaloric hyperproteic nutrition

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

Group Type EXPERIMENTAL

Hypocaloric hyperproteic nutrition

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Hypocaloric hyperproteic nutrition

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

Intervention Type DIETARY_SUPPLEMENT

Standard care

25 kcal per kg of body weight

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Hypocaloric hyperproteic Isocaloric

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario San Ignacio

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 Rugeles, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Javeriana

Locations

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Hospital Universitario San Ignacio

Bogotá, DC, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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SJ0079

Identifier Type: -

Identifier Source: org_study_id