Exploratory study to evaluate the efficacy and safety of nutritionally administering 1.5 g protein/kg/day vs. 1.0 g protein/kg/day in the catabolic phase of the critically ill patient on mechanical ventilatio

Phase 1

• Conditions: Acquired Weakness in the Intensive Care Unit (DAUCI) of the critically ill patient.; MedDRA version: 20.0Level: PTClassification code 10077255Term: Intensive care unit acquired weaknessSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2021-002329-56-ES
• Lead Sponsor: Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-25
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Must meet all criteria for inclusion:
1. Critically ill patient, adult > 18 years of age.
2. Admission to the ICU during the previous 48 hours.
3.Patients on invasive mechanical ventilation with a minimum expected duration of > 3 days.
4.Patient with a minimum expected duration of clinical nutrition of > 7 days from 48 hours after admission.
5.Written informed consent from the patient or the patient's legal representative or deferred written consent from the patient or the patient's legal representative.
6.Central venous access available for continuous infusion of study drugs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Refusal of informed consent
2. Acute renal failure (renal injury stage of 3)
3.Hepatic failure (cirrhosis or Chilg-Pugh Scale > 5).
4.Severe hepatic insufficiency with INR > 1.7 (prothrombin time < 50%) and encephalopathy.
5.Patients with COVID-19
6.Body Mass Index (BMI) > 40 or < 18.5 (morbid obesity or previous caloric malnutrition)
7.Pregnant patients
8.CNS pathologies (Glasgow < 6)
9.Peripheral SN pathologies
10.Patients with cognitive dysfunction/dementia or unable to follow instructions regarding MRC tests.
11.Severe muscular pathology
12.Participation in another clinical trial
13.Usual residence outside the region (impossibility of contact after discharge from the ICU).
14.Known hypersensitivity to milk protein or to any substance contained in Fresubin®.
15.Any congenital error in the metabolism of amino acids.
16.Previous inclusion in the present study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the occurrence and degree of Acquired Acute Critical Care Unit Weakness (ICUCI or ICUAW) in 2 groups of patients treated with different doses of protein (1.5.g/kg/day vs. 1.0 g/kg/day).;Secondary Objective: To compare the rate of:<br><br>- Infectious complications appeared in each of the two groups. <br>- Days of mechanical ventilation<br>- Metabolic and/or gastrointestinal complications<br>- Intra-ICU, in-hospital, 30 and 90 day mortality<br>- Intra-ICU and hospital days<br>- Urinary nitrogen excretion during time in ICU <br>- Quality of life at hospital discharge and 90 days;Primary end point(s): The primary endpoint will be Intensive Care Unit-Acquired Acute Care Weakness (ICUAW) as defined by a Medical Research Council (MRC Scale) score of less than 48, measured from ventilator weaning, every 4-6 days, on day 28 or at ICU discharge. (ANNEXES 4 and 4a);Timepoint(s) of evaluation of this end point: Every 4-6 days, on day 28 or at ICU discharge.