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

NCT07544147 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-04-22

No results posted yet for this 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

Conditions

  • Cardiac Surgery Associated - Acute Kidney Injury
  • Cardiac Surgery With Cardiopulmonary Bypass

Interventions

DRUG

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).

DRUG

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Kefang Guo, M.D. · Zhongshan hospital, Fudan university,Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-10-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07544147 on ClinicalTrials.gov