Hypocaloric Nutrition in Critically Ill Patients (RuRaL)
|Critically Ill||Dietary Supplement: Hypocaloric hyperproteic nutrition Dietary Supplement: Standard care||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial|
- SOFA (Sequential Organ Failure Assessment) Score [ Time Frame: 48 hours since nutritional regime starts ]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).
- Insulin Requirements [ Time Frame: Daily until day 21 or discharge from ICU ]This is an indirect measure of glycemic control, and is reported as a daily average.
|Study Start Date:||August 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Standard care
Patients will receive normal nutritional regime of around 25 kcal per kg.
Dietary Supplement: Standard care
25 kcal per kg of body weight
Other Name: Isocaloric
Experimental: Hypocaloric hyperproteic nutrition
15 kcal per kg of body weight and 1.7 grams of protein per kg
Dietary Supplement: Hypocaloric hyperproteic nutrition
15 kcal per kg of body weight and 1.7 grams of protein per kg.
Other Name: Hypocaloric hyperproteic
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531335
|Hospital Universitario San Ignacio|
|Bogota, DC, Colombia, 110311|
|Principal Investigator:||Saul Rugeles, MD||Pontificia Universidad Javeriana|