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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01531335
Other study ID # SJ0079
Secondary ID
Status Completed
Phase Phase 3
First received February 7, 2012
Last updated November 7, 2015
Start date August 2011
Est. completion date August 2012

Study information

Verified date November 2015
Source Lafrancol S.A.
Contact n/a
Is FDA regulated No
Health authority Colombia: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Hypocaloric hyperproteic nutrition
15 kcal per kg of body weight and 1.7 grams of protein per kg.
Standard care
25 kcal per kg of body weight

Locations

Country Name City State
Colombia Hospital Universitario San Ignacio Bogota DC

Sponsors (2)

Lead Sponsor Collaborator
Lafrancol S.A. Hospital Universitario San Ignacio

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 48 hours since nutritional regime starts No
Secondary Insulin Requirements This is an indirect measure of glycemic control, and is reported as a daily average. Daily until day 21 or discharge from ICU No
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