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Hypocaloric Enteral Nutrition in the Critically Ill Patient (hipoentnut)

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.
 
ClinicalTrials.gov Identifier: NCT02577211
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : November 10, 2015
Sponsor:
Collaborators:
Hospital Universitario San Ignacio
Pontificia Universidad Javeriana
Information provided by (Responsible Party):
Lafrancol S.A.

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). Both regimes will recive 1,7 g/Kg/dia 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: Hipocaloric enteral nutrition Dietary Supplement: Normocaloric enteral nutrition 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient
Study Start Date : December 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Hipocaloric enteral nutrition
15 kcal per kg of body weight and 1.7 grams of protein per kg.
Dietary Supplement: Hipocaloric enteral nutrition
15 kcal/Kg of body weight
Other Name: low caloric delivery

Active Comparator: Normocaloric enteral nutrition
25 kcal per kg of body weight and 1.7 grams of protein per kg.
Dietary Supplement: Normocaloric enteral nutrition
25 kcal/kg of body weight




Primary Outcome Measures :
  1. Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours. [ Time Frame: 48 hours after the onset of nutrition ]
    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. Units of insulin require in a day [ Time Frame: Within the first 4 days after the onset of nutrition ]
    This is an indirect measure of glycemic control, and is reported as a daily average of the units of insuline require in the first 4 days since nutritional regimen starts.

  2. Number of days the patient requires mechanical ventilation. [ Time Frame: Within the first 28 days after the onset of nutrition ]
    Measure daily

  3. Number of days in the intensive care unit [ Time Frame: Within the first 28 days after the onset of nutrition ]
    Measure daily

  4. Mortality to 28 days [ Time Frame: 28 days after the onset of nutrition ]
    We will interview each patient 28 days after the start of the study to assess the global mortality



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Ages Eligible for Study:   18 Years to 120 Years   (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
  • ICU patients

Exclusion Criteria:

  • Parenteral nutrition
  • Pregnancy
  • Diabetes
  • Liver failure
  • Transplantation or in transplant protocol
  • Previous nutrition support
  • Chronic Renal failure

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): NCT02577211


Locations
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Colombia
Hospital Universitario San Ignacio
Bogota, Colombia, 000000
Sponsors and Collaborators
Lafrancol S.A.
Hospital Universitario San Ignacio
Pontificia Universidad Javeriana
Investigators
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Principal Investigator: Saul J Rugeles, MD Hospital Universitario San Ignacio
Additional Information:
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Responsible Party: Lafrancol S.A.
ClinicalTrials.gov Identifier: NCT02577211    
Other Study ID Numbers: hnrct2
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015
Keywords provided by Lafrancol S.A.:
Critically ill
Enteral nutrition
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes