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Hypocaloric Nutrition in Critically Ill Patients (RuRaL)

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ClinicalTrials.gov Identifier: NCT01531335
Recruitment Status : Completed
First Posted : February 10, 2012
Results First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
Collaborator:
Hospital Universitario San Ignacio
Information provided by (Responsible Party):
Lafrancol S.A.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Critically Ill Dietary Supplement: Hypocaloric hyperproteic nutrition Dietary Supplement: Standard care Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012
Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Colombia
Hospital Universitario San Ignacio
Bogota, DC, Colombia, 110311
Sponsors and Collaborators
Lafrancol S.A.
Hospital Universitario San Ignacio
Investigators
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Principal Investigator: Saul Rugeles, MD Pontificia Universidad Javeriana
More Information
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Additional Information:

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Responsible Party: Lafrancol S.A.
ClinicalTrials.gov Identifier: NCT01531335    
Other Study ID Numbers: SJ0079
First Posted: February 10, 2012    Key Record Dates
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:
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Critical Illness
Disease Attributes
Pathologic Processes