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 @ 7:01 PM
Ignite Modification Date:
2025-12-24 @ 7:01 PM
NCT ID:
NCT05757557
Eligibility Criteria:
Inclusion Criteria:
* Cardiac surgery with CPB
* Age \> 18 years
* Signed informed consent
* CKD (cGFR \<60 mL/min/1.73 m2)
* Positive decision of council of physicians on individual safety of perioperative administration of NO
Exclusion Criteria:
* Emergency surgery (including that in ACS)
* cGFR \<15 mL/min/1.73 m2
* Administration of potentially nephrotoxic drugs within 24 hours before surgery (radiocontrast agents, antimicrobial therapy with aminoglycosides and / or amphotericin)
* Critical preoperative status (preoperative need for mechanical ventilation, inotropes, circulatory support)
* Pregnancy
* Ongoing enrolment in other randomized clinical trial
* Previous randomization in DEFENDER trial
* Active endocarditis and/or sepsis
* Pulmonary hypertension higher than stage II (systolic pulmonary pressure over 65 mmHg according to data of preoperative transthoracic echocardiography
* Condition after kidney transplantation
* Ongoing AKI caused by glomerulonephritis, interstitial nephritis, renal artery occlusion, or postrenal occlusion
* Cardiac surgery with hypothermic circulatory arrest
* Left ventricular ejection fraction \< 30%
* Single kidney
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05757557
Study Brief:
Protocol Section:
NCT05757557