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:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT04012333
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 years old;
2. Expected to remain mechanically ventilated for an additional 48 hours from screening;
3. And have one or more of the following risk factors that make them at high nutritional risk:
1. Low (≤25) or High BMI (≥35)
2. Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.).
3. Frailty (Clinical Frailty Scale 5 or more from proxy)
4. Sarcopenia (SARC-F score of 4 or more from proxy)
5. From point of screening, projected duration of mechanical ventilation \>4 days
Exclusion Criteria:
1. \>96 continuous hours of mechanical ventilation before enrollment
2. Expected death or withdrawal of life-sustaining treatments within 7 days from screening
3. Pregnancy
4. The responsible clinician feels that the patient either needs low or high protein
5. Absolute contraindication to EN
6. Severe metabolic disorders including electrolyte disorders, uncontrolled hyperglycemia, hyperlipidemia, hypophosphatemia.
7. Severe chronic liver disease (MELD-score \>20) or acute fulminant hepatitis.
8. Metabolic disorders involving impaired nitrogen utilization
9. Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted)
10. Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury)
11. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
12. Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre)
13. Intracranial or spinal process affecting motor function
14. Patients in hospital \>5 days prior to ICU admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04012333
Study Brief:
Protocol Section:
NCT04012333