Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT05918757
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05918757
Study Brief:
Protocol Section:
NCT05918757