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

NCT07544147 | Not Yet Recruiting

• 1 other identifier: B2026-171
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute Kidney Injury; Nitric Oxide; Cardiac surgery; Cardiopulmonary Bypass; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 7 days after surgery

Secondary Outcomes (7)

• AKI Stage and Duration

  Up to 7 days after surgery

• Major Adverse Kidney Events (MAKE)

  At hospital discharge, and at 30 days and 90 days after surgery

• Major Adverse Cardiovascular Events (MACE)

  At hospital discharge, and at 30 days and 90 days after surgery

• Postoperative Complications

  From end of surgery until hospital discharge (assessed up to 90 days)

• Duration of Mechanical Ventilation

  During intensive care unit (ICU) stay, up to 30 days

Other Outcomes (8)

• Intraoperative Methemoglobin Level

  During surgery (from induction until sternal closure)

• Nitrogen Dioxide Level

  During surgery (from start of iNO delivery until end of surgery)

• Dose Reduction or Discontinuation of Study Gas

  During surgery (from start of iNO delivery until end of surgery)

Study Arms (2)

Inhaled Nitric Oxide (iNO) Group

EXPERIMENTAL

Drug: Inhaled Nitric Oxide (iNO)

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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).

Inhaled Nitric Oxide (iNO) Group

Placebo DRUG

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kefang Guo, M.D.

  Zhongshan hospital, Fudan university,Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefang Guo, M.D.

CONTACT

86-021-64041990; dr_guokefang@163.com

Ying Yu, M.D.

CONTACT

86-021-64041990; yu.ying1@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The gas therapist who operates and adjusts the nitric oxide(NO) delivery device is unblinded. All other parties including patients, surgeons, anesthesiologists, ICU staff, outcome assessors, and data analysts are blinded. The device screen is covered with an opaque material in both the active and placebo groups to maintain blinding. The unblinded gas therapist does not participate in any other study procedures (e.g., patient management, data collection, or outcome assessment).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 22, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)