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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT05635227
Eligibility Criteria:
Inclusion Criteria:
1. Adult, i.e., above 18 years of age
2. Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.
Exclusion Criteria:
1. Acute surgery (i.e. off hours surgery)
2. Pregnancy or currently breastfeeding. Pregnancy in all fertile women will be ruled out by pregnancy testing prior to randomization.
3. Known endocarditis at time of screening
4. Previous participation in the trial
5. Active infection, including bacterial, viral, and/or fungal infection
6. Known hepatic cirrhosis
7. Known severe thrombocytopenia with thrombocyte levels \< 50 x 109/L
8. Known severe neutropenia with neutrocyte levels \< 2 x 109/L
9. On the waiting list for a heart transplant
10. Recipient of any major organ transplant
11. Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism
12. Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months.
13. Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer.
14. Known narrow-angle glaucoma
15. Known phenylketonuria
16. Type I diabetes
17. Known long QT syndrome
18. Known allergy for any of the included study drugs
19. Any condition, where participation in the study, in the investigator's opinion could put the subject at risk, confound the study results or interfere significantly with participation in the study
Patients with extracardiac arteriopathy (assessed as part of the pre-operative EuroSCORE) will be excluded from the intervention 'flow-targeted vs. pressure-targeted hemodynamic management during CPB'.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05635227
Study Brief:
Protocol Section:
NCT05635227