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:
NCT06261827
Eligibility Criteria:
Inclusion Criteria:
1. Cardiac surgery with CPB at current hospitalization.
2. Age \> 18 years.
3. Signed informed consent
Exclusion Criteria:
1. Emergency surgery.
2. Acute coronary syndrome 30 days before surgery.
3. Surgery for active infective endocarditis requiring antibiotic therapy.
4. Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, etc.).
5. Taking antibacterial drugs for 14 days preceding surgery
6. Other complications of the postoperative period (pneumothorax requiring pleural drainage, perioperative myocardial infarction accompanied by pulmonary edema, shock of any etiology during the current hospitalization).
7. Potentially dialysis-dependent stage 2 and higher acute kidney injury (according to KDIGO) in the early postoperative period (the criteria for potentially dialysis-dependent acute kidney injury will include patients with stage 2 acute kidney injury and: oliguria against the background of normo-hypervolemia and resistance to loop diuretics and/ or oliguria against the background of conducting infusion therapy due to hypovolemia and resistance to loop diuretics).
8. Continued mechanical ventilation.
9. Delirium.
10. Presence of tracheostomy.
11. Patient's participation in another clinical trial at the time of screening or within the previous 3 months.
12. Concomitant pulmonary disease with the need for respiratory support before surgery.
13. History of malignancy or other irreversible diseases/conditions with a 6- month mortality rate \>50%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06261827
Study Brief:
Protocol Section:
NCT06261827