Perioperative Nitric Oxide Prevents Acute Kidney Injury in Cardiac Surgery Patients With Chronic Kidney Disease (DEFENDER)
Acute Kidney Disease, Chronic Kidney Disease, Cardiac Surgery
About this trial
This is an interventional prevention trial for Acute Kidney Disease focused on measuring Acute Kidney Disease, Nitric Oxide, Chronic Kidney Disease, Cardiopulmonary Bypass, Cardiac Surgery, Prevention
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
Sites / Locations
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control group
80-ppm NO
Oxygen-air mixture without NO after intubation, during CPB, and six hours after surgery.
NO will be supplemented at 80-ppm concentration to cardiac surgery patients perioperative after trachea intubation, during CPB, and six hours after surgery.