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

NCT07544147 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Zhongshan Hospital

Phase

Not applicable

Started

2026-04-30

Last updated

2026-04-22

Condition(s) studied

Cardiac Surgery Associated - Acute Kidney InjuryCardiac Surgery With Cardiopulmonary Bypass

Investigational drug(s) / intervention(s)

Inhaled Nitric Oxide (iNO)Placebo

Inhaled Nitric Oxide (iNO): Inhaled 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: The 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.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Incidence of Acute Kidney Injury (AKI) within 7 Days After Surgery — Up to 7 days after surgery
Proportion of participants developing AKI within 7 days post-surgery, defined according to the KDIGO 2012 criteria.

Trial sites (1)

Facility	City	Region	Status
Zhongshan Hospital, Fudan University	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07544147 on ClinicalTrials.gov ↗ ← All trials in China