Efficacy and Safety of Administration of High Levels of Protein to Critically Ill Patients. (FISIO)
Intensive Care Unit Acquired Weakness
About this trial
This is an interventional other trial for Intensive Care Unit Acquired Weakness focused on measuring Critically ill, Mechanical ventilation, Parenteral nutrition, Enteral nutrition, Protein dose
Eligibility Criteria
Inclusion Criteria: Critically ill patient ICU admission during the previous 48h Patients on expected invasive mechanical ventilation for three days Patients with a minimum expected duration of clinical nutrition of at least seven days Written informed consent signed by the patient or the patient's legally authorized representative. Available central venous access for continuous infusion of the study drugs. Exclusion Criteria: Denied informed consent Acute renal failure (renal injury stage 3) Liver failure (cirrhosis or Child-Pugh Scale > 5) Severe liver failure with International Normalized Ratio (INR) > 1.7 (prothrombin time > 50%) and encephalopathy Patients with COVID-19-derived pneumonia Body Mass Index (BMI) > 40 or < 18.5 (morbid obesity or previous caloric malnutrition) Pregnant patients Central Nervous System pathologies (Glasgow < 6) Peripheral Nervous System pathologies interfering with study evaluations Patients with cognitive dysfunction/dementia or unable to follow instructions regarding MRC tests Severe muscular pathology Already participating in another clinical trial Impossibility to contact after ICU discharge to carry out the follow-up visit on day 90 Known hypersensitivity to milk protein or any of the components of the nutritional supplement Inborn errors in the amino acid metabolism Previous inclusion in the present study
Sites / Locations
- Hospital Universitario Germans Trias i PujolRecruiting
- Hospital Universitario de BellvitgeRecruiting
- Hospital General Universitario de CastellónRecruiting
- Hospital Universitario de BadajozRecruiting
- Hospital de BarbastroRecruiting
- Hospital Universitario de FuenlabradaRecruiting
- Hospital Universitario Infanta CristinaRecruiting
- Hospital de ManacorRecruiting
- Hospital General Universitario Santa LucíaRecruiting
- Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
- Hospital General Universitario Los Arcos del Mar MenorRecruiting
- Hospital Universitario Doctor Josep TruetaRecruiting
- Hospital Universitario Clínico San CecilioRecruiting
- Hospital Universitario San JorgeRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La PazRecruiting
- Hospital General Universitario Morales MeseguerRecruiting
- Hospital Universitario Regional de MálagaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Protein dose 1.5 g/kg/day
Protein dose 1.0 g/kg/day
Administration of 1.5 g of protein/kg/day in critically ill patients receiving invasive mechanical ventilation
Administration of 1.0 g of protein/kg/day in critically ill patients receiving invasive mechanical ventilation