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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT07164833
Eligibility Criteria:
Inclusion Criteria:
1. 19 to 90 years of age
2. Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA)
3. Body weight ≥ 30 kg
4. Participants with vital signs within the following ranges
* Temperature : 35.0\~37.5°C
* Blood pressure : Systolic blood pressure(SBP) 100\~160 mmHg, Diastolic blood pressure(DBP) \< 100 mmHg
* Pulse : 50\~100 bpm (regardless of drug use)
5. Willing to comply with the schedule and sign the informed consent
Exclusion Criteria:
1. Participants scheduled for emergent or salvage cardiac surgery
2. Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)
3. Participants with moderate renal impairement
4. Participants at risk of bleeding
5. Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease
6. Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery
7. Recipient of a solid organ or bone marrow transplantation
8. Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device
9. Active systemic bacterial, viral, or fungal infection
10. History of HIV
11. Positive serology test for HAV, HBV, HCV or Syphilis
12. Participants with impaired liver function due to cirrhosis, or those with 2x UNR blood levels of ALP, AST, or ALT, or with total bilirubin levels outside the normal range
13. Uncontrolled hypertension
14. History of congenital immunodeficiency
15. Genetic disorder with severe and abnormal bilirubin metabolism
16. Participants deemed unsuitable for the study in the discretion of the investigator
17. History of malignancy
18. Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury
19. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents
20. History of participation in other clinical trials within 30 days
21. Presence of a do-not-resuscitate order or life expectancy of \< 3 months
22. Female subjects of childbearing potential
23. Male subjects and their spouse/partner are not willing to use appropriate contraception, or if their spouse/partner is pregnant, breastfeeding or has a plan
24. Poorly controlled type 2 diabetes mellitus
25. New York Heart Association (NYHA) Class IV heart failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
90 Years
Study:
NCT07164833
Study Brief:
Protocol Section:
NCT07164833