Hypocaloric Nutrition in Critically Ill Patients

Critically Ill Clinical Trial

— RuRaL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531335
• Other study ID #: SJ0079
• 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

• Critical Illness
• Critically Ill

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

External Links

•   University's web page