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Hypocaloric Nutrition in Critically Ill Patients (RuRaL)

Primary Purpose

Critically Ill

Status

Completed

Phase

Phase 3

Locations

Colombia

Study Type

Interventional

Intervention

Hypocaloric hyperproteic nutrition

Standard care

About this trial

This is an interventional prevention trial for Critically Ill focused on measuring adults

Eligibility Criteria

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

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

Sites / Locations

Hospital Universitario San Ignacio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Hypocaloric hyperproteic nutrition

Arm Description

Patients will receive normal nutritional regime of around 25 kcal per kg.

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

Outcomes

Primary Outcome Measures

SOFA (Sequential Organ Failure Assessment) Score

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

This is an indirect measure of glycemic control, and is reported as a daily average.

Full Information

NCT ID

NCT01531335

First Posted

February 7, 2012

Last Updated

November 7, 2015

Sponsor

Lafrancol S.A.

Collaborators

Hospital Universitario San Ignacio

1. Study Identification

Unique Protocol Identification Number

NCT01531335

Brief Title

Hypocaloric Nutrition in Critically Ill Patients

Acronym

RuRaL

Official Title

Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lafrancol S.A.

Collaborators

Hospital Universitario San Ignacio

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). 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

adults

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard care

Arm Type

Active Comparator

Arm Description

Patients will receive normal nutritional regime of around 25 kcal per kg.

Arm Title

Hypocaloric hyperproteic nutrition

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Hypocaloric hyperproteic nutrition

Other Intervention Name(s)

Hypocaloric hyperproteic

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Standard care

Other Intervention Name(s)

Isocaloric

Intervention Description

25 kcal per kg of body weight

Primary Outcome Measure Information:

Title

SOFA (Sequential Organ Failure Assessment) Score

Description

Time Frame

48 hours since nutritional regime starts

Secondary Outcome Measure Information:

Title

Insulin Requirements

Description

This is an indirect measure of glycemic control, and is reported as a daily average.

Time Frame

Daily until day 21 or discharge from ICU

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saul Rugeles, MD

Organizational Affiliation

Pontificia Universidad Javeriana

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario San Ignacio

City

Bogota

State/Province

ZIP/Postal Code

110311

Country

Colombia

12. IPD Sharing Statement

Links:

URL

http://puj-portal.javeriana.edu.co/portal/page/portal/PORTAL_VERSION_2009_2010/es_inicio

Description

University's web page

Learn more about this trial

Hypocaloric Nutrition in Critically Ill Patients

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