Critically Ill | Hypocaloric Nutrition in Critically Ill Patients
Critically Ill research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Hypocaloric hyperproteic nutrition15 kcal per kg of body weight and 1.7 grams of protein per kg.
Dietary Supplement:Standard care25 kcal per kg of body weight
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Standard carePatients will receive normal nutritional regime of around 25 kcal per kg.
Hypocaloric hyperproteic nutrition15 kcal per kg of body weight and 1.7 grams of protein per kg
Start Date: August 2011
Completed Date: August 2012
Phase: Phase 3
Primary Outcome: SOFA (Sequential Organ Failure Assessment) Score
Secondary Outcome: Insulin Requirements
Study sponsors, principal investigator, and references
Principal Investigator: Saul Rugeles, MD
Lead Sponsor: Lafrancol S.A.
Collaborator: Hospital Universitario San Ignacio