Hypocaloric Nutrition in Critically Ill Patients (RuRaL)

November 7, 2015 updated by: Lafrancol S.A.

Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • DC
      • Bogota, DC, Colombia, 110311
        • Hospital Universitario San Ignacio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (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

Exclusion Criteria:

  • parenteral nutrition
  • pregnancy
  • diabetes
  • liver or renal failure
  • transplantation
  • admitted from another hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard care
Patients will receive normal nutritional regime of around 25 kcal per kg.
Dietary supplement: Standard care
25 kcal per kg of body weight
Other Names:
  • Isocaloric
Experimental: Hypocaloric hyperproteic nutrition
15 kcal per kg of body weight and 1.7 grams of protein per kg
Dietary supplement: Hypocaloric hyperproteic nutrition
15 kcal per kg of body weight and 1.7 grams of protein per kg.
Other Names:
  • Hypocaloric hyperproteic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOFA (Sequential Organ Failure Assessment) Score
Time Frame: 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).
48 hours since nutritional regime starts

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Requirements
Time Frame: Daily until day 21 or discharge from ICU
This is an indirect measure of glycemic control, and is reported as a daily average.
Daily until day 21 or discharge from ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lafrancol S.A.

Collaborators

Hospital Universitario San Ignacio

Investigators

  • Principal Investigator: Saul Rugeles, MD, Pontificia Universidad Javeriana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

November 7, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ0079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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