Inhaled Nitric Oxide for Prevention of Postoperative AKI in High-Risk Cardiac Surgery Patients

Starting soon · Not applicable · Has a placebo group

Conditions studied: Cardiac Surgery Associated - Acute Kidney Injury, Cardiac Surgery With Cardiopulmonary Bypass

In brief

The goal of this clinical trial is to learn if giving inhaled nitric oxide during heart surgery can prevent acute kidney injury (AKI) in patients who are at high risk of developing this complication. AKI is a serious problem after heart surgery and can lead to longer hospital stays, higher costs, and increased risk of death or long-term kidney disease. Currently, there is no effective medicine to prevent AKI after heart surgery. The main questions it aims to answer are: * Does inhaled nitric oxide reduce the chance of developing AKI within 7 days after heart surgery compared to placebo? * Does inhaled nitric oxide help preserve kidney function up to 90 days after surgery? Researchers will compare inhaled nitric oxide (the device is turned on) to a placebo (the same device is connected to the breathing circuit but not turned on, so no nitric oxide is given). The device panel is covered so that both participants and the research team do not know who receives active treatment or placebo (double-blind). Participants in this study will: * Have the nitric oxide device connected to their breathing circuit during heart surgery; they will receive either active nitric oxide or no nitric oxide (device off) * Provide blood and urine samples to test kidney function during and after surgery * Be followed for 90 days after surgery to monitor kidney health and any side effects

Key facts

Study ID: NCT07544147
Run by: Shanghai Zhongshan Hospital
People needed: 330
Starts: 2026-04-30
Expected to finish: 2028-12-31
Last updated by the study team: 2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years
Scheduled for elective cardiac surgery with cardiopulmonary bypass, including valve surgery and/or coronary artery bypass grafting (CABG)
Mayo Clinic renal risk score ≥2

You may not qualify if…

Emergency surgery
Cardiac or major vascular surgery requiring deep hypothermic circulatory arrest
Use of potentially nephrotoxic drugs (e.g., radiocontrast agents, aminoglycosides, amphotericin) within 24 hours before surgery
Preoperative heart failure or low cardiac output syndrome requiring life support devices (ECMO, Impella or other left ventricular assist devices, mechanical ventilation), or left ventricular ejection fraction <30%, or other equivalent severe cardiac dysfunction
Receipt of inhaled nitric oxide or inhaled prostacyclin within 7 days before randomization
End-stage renal disease with eGFR <15 mL/min, or currently receiving renal replacement therapy, or prior kidney transplantation
Hemophilia A or B
Other end-stage chronic disease with estimated life expectancy <1 year (as assessed by the attending physician)
Pregnancy
Active endocarditis or other active infection

Where it is running

Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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