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).
It is known that protein metabolism is altered in critically ill patients due to metabolic alterations derived from stress. This critical situation is manifested by a severe catabolic alteration, especially in the first week, which is fundamentally characterized by severe glucose intolerance and the use of the protein itself as a metabolic substrate. Despite protein synthesis is increased, this is insufficient to compensate for the high protein degradation rate, which leads, among others, to muscle deterioration resulting in increased morbidity and mortality. This muscle destruction has been implicated in the early appearance of Intensive care unit-acquired weakness (ICUAW). Although the pathophysiology of ICUAW is multifactorial, protein intake may play an key role in its treatment. However, protein intake cannot reduce muscle destruction, but it can stimulate protein synthesis. Current evidence supports that the administration of early artificial nutritional support with a high protein intake can improve the clinical course of critically ill patients. However, there is still no consensus on the exact amount of protein needed to be administered to these patients in order to reduce adverse outcomes and prevent ICUAW. Thus the aim of this study is to evaluate the effect of a nutritional supplementation containing 1.5 g of protein/kg/day vs 1.0 g of protein /kg/day in critically ill patients receiving mechanical ventilation on the development and degree of ICUAW.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
200
Administration of 1.5 g of protein/kg/day via enteral/parenteral nutrition
Administration of 1.0 g of protein/kg/day via enteral/parenteral nutrition
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
...and 8 more locations
Change of intensive care unit acquired weakness (ICUAW).
Determined by Medical Research Council sum score (MRC-SS). Diagnosis of ICUAW if MRC-SS \< 48 (maximun score 60).
Time frame: Baseline, weekly in ICU up to 28 days after mechanical ventilation termination, throughout hospital stay, an expected average of 6 weeks, and 90 days after hospital discharge.
Muscle Strength.
Dynamometry.
Time frame: Up to 6 months.
Active mobility.
Determined by Intensive Care Unit Mobility Scale (ICUMS). Scored from 0 to 10 being 0 no activity, lying in bed, and 10 walking independently without a gait aid.
Time frame: Up to 6 months.
Nosocomial infections.
Centers for disease control and prevention (CDC).
Time frame: Throughout hospital stay, an expected average of 6 weeks.
Mechanical ventilation.
Number of days receiving mechanical ventilation.
Time frame: Up to 1 month.
Gastrointestinal complications.
Gastric residual volume, diarrhea, vomiting or regurgitation, abdominal distension, constipation.
Time frame: Throughout hospital stay, an expected average of 6 weeks.
Metabolic complications.
Glycemia, fluid intake, electrolytes/trace element determination, hypertriglyceridemia, liver disfunction, cholestasis, necrosis or mixed dysfunction, overfeeding.
Time frame: Throughout hospital stay, an expected average of 6 weeks.
Mortality rate.
Number of deaths/total participants
Time frame: Up to 6 months.
Length of ICU and hospital stay.
Number of days of hospitalization.
Time frame: Throughout hospital stay, an expected average of 6 weeks.
Quality of life index.
European Quality of Life-5 Dimensions (EQ-5D). Scored from 0 to 100 being 0 the worst health imaginable and 100 the best health imaginable.
Time frame: Up to 6 months.
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