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Efficacy and Safety of Administration of High Levels of Protein to Critically Ill Patients.
Sponsor: Spanish Society of Critical Care Medicine and Coronary Units
Summary
Critically ill patients are known to develop serious nutritional deterioration during the course of their disease. They develop, from the beginning, a multifactorial protein malnutrition that relates to a poor clinical course and the development of weakness. Due to the increased protein catabolism in this type of patient, there is a rapid degradation of muscle mass and loss of functional proteins, and therefore nutritional support is mandatory. Indeed, achieving a high protein intake may promote a better evolution of the critically ill patient, i.e., maintenance of muscle protein, less deterioration of muscle strength, lower Intensive care unit-acquired weakness (ICUAW), lower mortality, decrease in the number of infections, decrease in days on mechanical ventilation, and days of hospital stay and in ICU. The goal of this clinical trial is to compare the appearance and degree of ICUAW in critically ill patients receiving invasive mechanical ventilation treated with two different doses of protein (1.5 g/kg/day vs.1.0 g/kg/day).
Official title: Exploratory Study to Evaluate the Efficacy and Safety of Nutritional Administration of 1.5 g of Protein/kg/Day Versus 1.0 g of Protein/kg/Day in the Catabolic Phase of Critically Ill Patients Receiving Mechanical Ventilation.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-01-01
Completion Date
2024-06-30
Last Updated
2024-06-20
Healthy Volunteers
No
Conditions
Interventions
Protein dose 1.5 g/kg/day
Administration of 1.5 g of protein/kg/day via enteral/parenteral nutrition
Protein dose 1.0 g/kg/day
Administration of 1.0 g of protein/kg/day via enteral/parenteral nutrition
Locations (18)
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario de Castellón
Castellon, Castelló, Spain
Hospital Universitario de Badajoz
Badajoz, Extremadura, Spain
Hospital de Barbastro
Barbastro, Huesca, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Infanta Cristina
Parla, Madrid, Spain
Hospital de Manacor
Manacor, Mallorca, Spain
Hospital General Universitario Santa Lucía
Cartagena, Murcia, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital General Universitario Los Arcos del Mar Menor
Pozo-Aledo, Murcia, Spain
Hospital Universitario Doctor Josep Trueta
Girona, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital Universitario San Jorge
Huesca, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Regional de Málaga
Málaga, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain