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 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT03715868
Eligibility Criteria:
Inclusion Criteria:
1. Men and women ≥50 years of age
2. Caucasian ethnicity
3. Scheduled cardiac surgery with use of the heart-lung machine with a lead time of at least 9 days
4. Written informed consent
Exclusion Criteria:
1. Chronic renal replacement therapy
2. Status post kidney transplantation
3. Vegetarian lifestyle
4. BMI \<18.5 kg/m2
5. Calorie-reduced diet within the preceding 4 weeks
6. Underlying wasting disease
7. Uncontrolled local or systemic infection
8. Contraindication for enteral nutrition
9. Known allergy to or intolerance of the ingredients of the formula diets used
10. Pregnancy or breastfeeding
11. Absence of safe contraceptive measures or non-occurrence of menopause (in women)
12. Participation in other interventional trials
13. Persons who are in a dependency/employment relationship with the investigators
14. Accommodation in an institution by judicial or administrative order.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03715868
Study Brief:
Protocol Section:
NCT03715868