Hypocaloric Nutrition in Critically Ill Patients (RuRaL)

Lafrancol

Status and phase: Completed; Phase 3

Conditions: Critically Ill

Treatments: Dietary Supplement: Hypocaloric hyperproteic nutrition; Dietary Supplement: Standard care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01531335

SJ0079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Standard care

Hypocaloric hyperproteic nutrition

Experimental group

Description:

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

Treatment:

Dietary Supplement: Hypocaloric hyperproteic nutrition