Perioperative Nitric Oxide Prevents Acute Kidney Injury in Cardiac Surgery Patients With Chronic Kidney Disease

• Status: Not yet recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The protective nitric oxide (NO) effects are mediated by selective pulmonary vasodilation and improvement of arterial oxygenation in hypoxemic patients by reducing intrapulmonary shunting and improving ventilation-perfusion coordination. Inhaled NO has been used for years to treat acute respiratory failure and pulmonary hypertension in anesthesia and intensive care. The nephroprotective role of NO was studied in an experimental model of contrast-induced nephropathy. The primary aim of this prospective, double-blind, randomized, parallel-group, controlled trial is to test the hypothesis that perioperative conditioning of patients with NO at a dose of 80 ppm, obtained by plasma-chemical synthesis technology, through a ventilator and an extracorporeal circulation circuit reduces the incidence of acute kidney injury (AKI) in patients with an initially high risk of kidney damage due to the presence of preoperative chronic kidney disease (CKD). The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk NRMC for elective surgery with high risk of AKI in the perioperative period

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Treatments: Nitric Oxide

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