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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT02564159
Eligibility Criteria:
Study Population
Subjects will be enrolled from 2 venues:
1. Adults ICU patients (\> 18 years) requiring period of mechanical ventilation. Subjects affiliated with an appropriate social security system
2. Adults patients admit requiring ICU length of stay \< 48h after eligible surgery
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1. MALICUS Study
Inclusion Criteria:
\- Patient requiring invasive mechanical ventilation
\- Expected duration of ventilation longer than 48 hours
\- Age \> 18 years
* Subjects affiliated with an appropriate social security system
Non inclusion Criteria:
\- Invasive mechanical ventilation started for more than 48 hours
\- Patient severely malnourished at baseline (at least one of the following criteria)
* Prealbuminemia \< 0,11 g/L
* BMI ≤ 18,5 (or ≤ 22 beyond 70 years)
* Unintentional weight loss \> 5% in the previous month or \> 10% in the last 6 months - Glomerular nephropathy history/nephrotic syndrome, chronic renal failure (MDRD \< 30 ml/min), liver cirrhosis or exudative gastro-enteropathy - Glucocorticoid (\> 10 mg / day of prednisone equivalent ) long-term therapy ( \> 1 month) - Impossible ultrasound measure of anterolateral diameter for the two quadriceps muscles
\- Neuromuscular disease that can cause muscle atrophy at a lower limb, without any support in the ICU
2. Control group - BIOBANK-MALICUS
Inclusion criteria:
* Elective surgery requiring an ICU stay (neurosurgery, vascular surgery, thoracic surgery)
* Expected duration of ventilation shorter than 48 hours
Non inclusion criteria:
• Elective surgery with cardiopulmonary bypass
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02564159
Study Brief:
Protocol Section:
NCT02564159