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Hypocaloric Nutrition in Critically Ill Patients (RuRaL)

This study is currently recruiting participants.
Verified February 2012 by Lafrancol S.A.
Sponsor:
Collaborator:
Hospital Universitario San Ignacio
Information provided by (Responsible Party):
Lafrancol S.A.
ClinicalTrials.gov Identifier:
NCT01531335
First received: February 7, 2012
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Critically Ill
 Dietary Supplement: Hypocaloric hyperproteic nutrition
Dietary Supplement: Standard care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lafrancol S.A.:

Primary Outcome Measures:
  • SOFA (Sequential Organ Failure Assessment) score [ Time Frame: Every 48 hours since nutritional regime starts and until discharge from ICU ] [ Designated as safety issue: No ]
    SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, CNS, liver and renal. Each system gets a score from 0 to 4; the maximum SOFA score is 24.


Secondary Outcome Measures:
  • Insulin requirements [ Time Frame: Daily until day 21 or discharge from ICU ] [ Designated as safety issue: No ]
    This is an indirect measure of glycemic control.


Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Hypocaloric hyperproteic

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531335

Contacts
Contact: Saul Rugeles, MD 57 315 8907238 sjrugeles@husi.org.co

Locations
Colombia
Hospital Universitario San Ignacio Recruiting
Bogota, DC, Colombia, 110311
Contact: Saul Rugeles, MD     57 315 8907238     sjrugeles@husi.org.co    
Contact: Juan-David Rueda, MD     57 3104401922     juandavidruedamd@gmail.com    
Sub-Investigator: Juan-Carlos Ayala, MD            
Sub-Investigator: Carlos Diaz, MD student            
Sub-Investigator: Diego Rosselli, MD            
Sponsors and Collaborators
Lafrancol S.A.
Hospital Universitario San Ignacio
Investigators
Principal Investigator: Saul Rugeles, MD Pontificia Universidad Javeriana
  More Information

Additional Information:
University's web page  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Lafrancol S.A.
ClinicalTrials.gov Identifier: NCT01531335     History of Changes
Other Study ID Numbers: SJ0079
Study First Received: February 7, 2012
Last Updated: February 8, 2012
Health Authority: Colombia: Institutional Review Board

Keywords provided by Lafrancol S.A.:
adults

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013