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
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
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
Parallel
Inhaled Nitric Oxide (iNO)
DrugInhaled nitric oxide(iNO) at 80 ppm is delivered via the ventilator circuit during cardiopulmonary bypass and until the end of surgery. The gas is administered using the INOwill N200 delivery device (which is turned ON).
Placebo
DrugThe same NO device is connected to the ventilator circuit but remains TURNED OFF, so no nitric oxide is delivered. The device screen is covered to maintain blinding. Participants in the placebo group receive no active drug.
Incidence of Acute Kidney Injury (AKI) within 7 Days After Surgery
Proportion of participants developing AKI within 7 days post-surgery, defined according to the KDIGO 2012 criteria.
AKI Stage and Duration
Maximum KDIGO stage (1, 2, or 3) of AKI and total duration (days) of AKI during the first 7 postoperative days.
Major Adverse Kidney Events (MAKE)
Composite of all-cause death, new need for renal replacement therapy, or a ≥25% decline in eGFR from baseline. Assessed during hospital stay and at 30 and 90 days after discharge.
Major Adverse Cardiovascular Events (MACE)
Composite of myocardial infarction, stroke, or all-cause death. Assessed during hospital stay and at 30 and 90 days after discharge.
Postoperative Complications
Occurrence of pneumonia, stroke, myocardial infarction, or other major complications during the postoperative hospital stay.
Intraoperative Methemoglobin Level
Maximum methemoglobin level (%) measured by intraoperative blood gas analysis.
Nitrogen Dioxide Level
Maximum nitrogen dioxide level (ppm) measured in real time by the NO delivery device.
Dose Reduction or Discontinuation of Study Gas
Number of participants in whom the study gas was reduced or stopped because methemoglobin exceeded 5% or nitrogen dioxide exceeded 3 ppm.
Adverse Events Related to Study Gas Administration
Any adverse event that leads to early discontinuation or prolonged use of the study gas, including worsening oxygenation, elevated pulmonary artery pressure causing hypoxemia, systemic hypotension, bradycardia, or right heart failure.
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This trial is not recruiting at the moment. You can still explore other options:
