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ACTIVE NOT RECRUITING
NCT05918757
NA

Efficacy and Safety of Administration of High Levels of Protein to Critically Ill Patients.

Sponsor: Spanish Society of Critical Care Medicine and Coronary Units

View on ClinicalTrials.gov

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

Interventions

OTHER

Protein dose 1.5 g/kg/day

Administration of 1.5 g of protein/kg/day via enteral/parenteral nutrition

OTHER

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