Cardiac Surgery Associated - Acute Kidney InjuryNCT07544147
Inhaled Nitric Oxide for Prevention of Postoperative AKI in High-Risk Cardiac Surgery Patients
A study testing Inhaled Nitric Oxide (iNO) in people with Cardiac Surgery Associated - Acute Kidney Injury and Cardiac Surgery With Cardiopulmonary Bypass, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Associated - Acute Kidney Injury, Cardiac Surgery With Cardiopulmonary Bypass
- What is being tested?
- Inhaled Nitric Oxide (iNO)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Kefang Guo, M.D., 86-021-64041990, dr_guokefang@163.com
About this study
Official title: Intraoperative Inhaled Nitric Oxide to Reduce Postoperative Acute Kidney Injury in High-Risk Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
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:
Read more
- 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
Read the detailed description
This is a single-center, prospective, randomized, double-blind, placebo-controlled superiority trial. It evaluates whether intraoperative inhaled nitric oxide (iNO) at 80 ppm reduces the incidence of acute kidney injury (AKI) within 7 days after cardiac surgery with cardiopulmonary bypass (CPB) in high-risk patients (Mayo Clinic renal risk score ≥2).
Intervention: Patients receive inhaled nitric oxide at 80 ppm via the ventilator circuit during CPB and until the end of surgery.
Control: The same device is connected but remains turned off (no iNO delivery). The device screen is covered in both groups to maintain blinding.
Randomization and blinding: Randomization (1:1) uses a blocked scheme with allocation concealment. Patients, surgeons, anesthesiologists, ICU staff, and outcome assessors are blinded. A dedicated gas therapist (not otherwise involved) manages the device.
Standardized management: All patients receive standardized anesthesia, CPB, and KDIGO-recommended AKI prevention bundle (MAP>55 mmHg, goal-directed perfusion).
Safety monitoring: Intraoperative methemoglobin (blood gas) and nitrogen dioxide (device readout) are monitored with predefined safety thresholds for dose adjustment.
Exploratory biomarker substudy (optional): Blood and urine samples are collected at perioperative time points to measure biomarkers of kidney injury and inflammation.
Follow-up: In-hospital outcomes (complications, ventilation duration, length of stay) and telephone follow-up at 30 and 90 days for major adverse kidney and cardiovascular events.
Sample size: Approximately 330 participants (1:1) are planned.
Statistical analysis: The primary analysis compares 7-day AKI incidence between groups with a two-sided α=0.05. Secondary outcomes will be analyzed using appropriate parametric or non-parametric methods.
- Conditions
- Cardiac Surgery Associated - Acute Kidney Injury, Cardiac Surgery With Cardiopulmonary Bypass
- Being tested
- Inhaled Nitric Oxide (iNO), Placebo
- Keywords
- Acute Kidney Injury, Nitric Oxide, Cardiac surgery, Cardiopulmonary Bypass, Randomized Controlled Trial
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Nitric Oxide (iNO)Drug
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).
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide (iNO) Group | Experimental | Not described Receives: Drug: Inhaled Nitric Oxide (iNO) |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days after surgery
Secondary outcomes (7)
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.
Measured: Up to 7 days after surgery
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.
Measured: At hospital discharge, and at 30 days and 90 days after surgery
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.
Measured: At hospital discharge, and at 30 days and 90 days after surgery
Postoperative Complications
Occurrence of pneumonia, stroke, myocardial infarction, or other major complications during the postoperative hospital stay.
Measured: From end of surgery until hospital discharge (assessed up to 90 days)
Duration of Mechanical Ventilation
Total time (hours) from end of surgery until successful extubation.
Measured: During intensive care unit (ICU) stay, up to 30 days
ICU Length of Stay
Total number of days from ICU admission to ICU discharge.
Measured: During hospitalization, up to 90 days
Hospital Length of Stay
Total number of days from surgery to hospital discharge.
Measured: During hospitalization, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Associated - Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kefang Guo, M.D., Principal investigator, Zhongshan hospital, Fudan university,Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544147
- Sponsor's protocol ID
- B2026-171
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data (IPD). The informed consent form signed by participants did not include provisions for sharing de-identified data with external researchers beyond the primary study team.