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Hypocaloric Nutrition in Critically Ill Patients (RuRaL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01531335
First Posted: February 10, 2012
Last Update Posted: December 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospital Universitario San Ignacio
Information provided by (Responsible Party):
Lafrancol S.A.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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

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

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 80
Study Start Date: August 2011
Study Completion Date: August 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531335


Locations
Colombia
Hospital Universitario San Ignacio
Bogota, DC, Colombia, 110311
Sponsors and Collaborators
Lafrancol S.A.
Hospital Universitario San Ignacio
Investigators
Principal Investigator: Saul Rugeles, MD Pontificia Universidad Javeriana
  More Information

Additional Information:
Responsible Party: Lafrancol S.A.
ClinicalTrials.gov Identifier: NCT01531335     History of Changes
Other Study ID Numbers: SJ0079
First Submitted: February 7, 2012
First Posted: February 10, 2012
Results First Submitted: December 16, 2013
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015
Last Verified: November 2015

Keywords provided by Lafrancol S.A.:
adults

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes