Hypocaloric Enteral Nutrition in the Critically Ill Patient (hipoentnut)
|ClinicalTrials.gov Identifier: NCT02577211|
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : November 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill||Dietary Supplement: Hipocaloric enteral nutrition Dietary Supplement: Normocaloric enteral nutrition||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Hipocaloric enteral nutrition
15 kcal per kg of body weight and 1.7 grams of protein per kg.
Dietary Supplement: Hipocaloric enteral nutrition
15 kcal/Kg of body weight
Other Name: low caloric delivery
Active Comparator: Normocaloric enteral nutrition
25 kcal per kg of body weight and 1.7 grams of protein per kg.
Dietary Supplement: Normocaloric enteral nutrition
25 kcal/kg of body weight
- Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours. [ Time Frame: 48 hours after the onset of nutrition ]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).
- Units of insulin require in a day [ Time Frame: Within the first 4 days after the onset of nutrition ]This is an indirect measure of glycemic control, and is reported as a daily average of the units of insuline require in the first 4 days since nutritional regimen starts.
- Number of days the patient requires mechanical ventilation. [ Time Frame: Within the first 28 days after the onset of nutrition ]Measure daily
- Number of days in the intensive care unit [ Time Frame: Within the first 28 days after the onset of nutrition ]Measure daily
- Mortality to 28 days [ Time Frame: 28 days after the onset of nutrition ]We will interview each patient 28 days after the start of the study to assess the global mortality
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577211
|Hospital Universitario San Ignacio|
|Bogota, Colombia, 000000|
|Principal Investigator:||Saul J Rugeles, MD||Hospital Universitario San Ignacio|