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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT04205760
Eligibility Criteria:
Inclusion Criteria:
1. Given informed consent
2. Adult patients (≥18 years)
3. Patients undergoing elective LVAD implantation Additional cardiac surgery, such as bypass grafting, or valve repair is permitted
Exclusion Criteria:
1. Hospital admission \<5 days prior to planned LVAD implantation
2. Patients on ECMO or INTERMACS\<1
3. Patients already receiving nutrition support on hospital admission
4. Enteral nutrition is contraindicated.
5. Pregnant or lactating patients
6. Patients with clinical fulminant hepatic failure
7. Patients with cirrhosis Child's Class C Liver Disease
8. Patients with clinical kidney failure or requiring hemodialysis
9. Known allergy or intolerance to study nutrients
10. Intracranial or spinal process affecting motor function
11. Lower extremity impairments that prevent cycling
12. Disabling neuropsychiatric disorders or language barriers
13. Weight \> 150 kg
14. Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case by case basis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04205760
Study Brief:
Protocol Section:
NCT04205760