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Hypocaloric Enteral Nutrition in the Critically Ill Patient (hipoentnut)

Primary Purpose

Critically Ill

Status
Completed
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Hipocaloric enteral nutrition
Normocaloric enteral nutrition
Sponsored by
Lafrancol S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring Critically ill, Enteral nutrition

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario San Ignacio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hipocaloric enteral nutrition

Normocaloric enteral nutrition

Arm Description

15 kcal per kg of body weight and 1.7 grams of protein per kg.

25 kcal per kg of body weight and 1.7 grams of protein per kg.

Outcomes

Primary Outcome Measures

Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.
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

Units of insulin require in a day
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.
Number of days the patient requires mechanical ventilation.
Measure daily
Number of days in the intensive care unit
Measure daily
Mortality to 28 days
We will interview each patient 28 days after the start of the study to assess the global mortality

Full Information

First Posted
October 10, 2015
Last Updated
November 7, 2015
Sponsor
Lafrancol S.A.
Collaborators
Hospital Universitario San Ignacio, Pontificia Universidad Javeriana
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1. Study Identification

Unique Protocol Identification Number
NCT02577211
Brief Title
Hypocaloric Enteral Nutrition in the Critically Ill Patient
Acronym
hipoentnut
Official Title
Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lafrancol S.A.
Collaborators
Hospital Universitario San Ignacio, Pontificia Universidad Javeriana

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
Critically ill, Enteral nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hipocaloric enteral nutrition
Arm Type
Experimental
Arm Description
15 kcal per kg of body weight and 1.7 grams of protein per kg.
Arm Title
Normocaloric enteral nutrition
Arm Type
Active Comparator
Arm Description
25 kcal per kg of body weight and 1.7 grams of protein per kg.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hipocaloric enteral nutrition
Other Intervention Name(s)
low caloric delivery
Intervention Description
15 kcal/Kg of body weight
Intervention Type
Dietary Supplement
Intervention Name(s)
Normocaloric enteral nutrition
Intervention Description
25 kcal/kg of body weight
Primary Outcome Measure Information:
Title
Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.
Description
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).
Time Frame
48 hours after the onset of nutrition
Secondary Outcome Measure Information:
Title
Units of insulin require in a day
Description
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.
Time Frame
Within the first 4 days after the onset of nutrition
Title
Number of days the patient requires mechanical ventilation.
Description
Measure daily
Time Frame
Within the first 28 days after the onset of nutrition
Title
Number of days in the intensive care unit
Description
Measure daily
Time Frame
Within the first 28 days after the onset of nutrition
Title
Mortality to 28 days
Description
We will interview each patient 28 days after the start of the study to assess the global mortality
Time Frame
28 days after the onset of nutrition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saul J Rugeles, MD
Organizational Affiliation
Hospital Universitario San Ignacio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario San Ignacio
City
Bogota
ZIP/Postal Code
000000
Country
Colombia

12. IPD Sharing Statement

Links:
URL
http://puj-portal.javeriana.edu.co/portal/page/portal/Facultad%20de%20Medicina/ptl_dpto_cirugral/Publicaciones
Description
Webpage of the surgery department

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Hypocaloric Enteral Nutrition in the Critically Ill Patient

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