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

February 7, 2012
February 8, 2012
August 2011
August 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01531335 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Hypocaloric Nutrition in Critically Ill Patients
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Critically Ill
  • Dietary Supplement: Hypocaloric hyperproteic nutrition
    15 kcal per kg of body weight and 1.7 grams of protein per kg.
    Other Name: Hypocaloric hyperproteic
  • Dietary Supplement: Standard care
    25 kcal per kg of body weight
    Other Name: Isocaloric
  • Active Comparator: Standard care
    Patients will receive normal nutritional regime of around 25 kcal per kg.
    Intervention: Dietary Supplement: Standard care
  • Experimental: Hypocaloric hyperproteic nutrition
    15 kcal per kg of body weight and 1.7 grams of protein per kg
    Intervention: Dietary Supplement: Hypocaloric hyperproteic nutrition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Saul Rugeles, MD 57 315 8907238 sjrugeles@husi.org.co
Colombia
 
NCT01531335
SJ0079
Yes
Lafrancol S.A.
Lafrancol S.A.
Hospital Universitario San Ignacio
Principal Investigator: Saul Rugeles, MD Pontificia Universidad Javeriana
Lafrancol S.A.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP