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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT04143503
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years and ≤95 years, male or female
2. Hospitalised in a medical, surgical, or trauma ICU for at least five consecutive calendar days and either admitted to the ICU during the predefined screening month or admitted to the ICU maximally 4 days before start of the screening month
3. BMI ≥18.5 kg/m2 and ≤45 kg/m2
4. Written informed consent or requirements of local/national ethical committee
Exclusion Criteria:
1. Burn injury
2. Pre-existing neuromuscular or psychiatric disorders that preclude proper assessment of functional status
3. Severe hypoxic brain injury or severe neurological diagnosis (e.g. meningitis, encephalitis, brain trauma, spinal cord injury) at the time of ICU admission that precludes proper assessment of functional status
4. Receiving home parenteral nutrition at the time of ICU admission (e.g. due to short bowel syndrome)
5. Receiving home enteral nutrition (tube feeding) at the time of ICU admission
6. Chronic invasive or chronic non-invasive ventilatory support before ICU admission
7. Patients with a legal representative in place before ICU admission
8. Admission to the ICU for palliative care
9. Previous participation in this study (if the screening month is repeated and a patient is re-admitted to the ICU during the repeated screening month, only ICU data collected for that patient during the original screening month will be included)
10. Concurrent enrolment in a nutrition-related interventional study at the time of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT04143503
Study Brief:
Protocol Section:
NCT04143503