Using Nitric Oxide to Improve Recovery in Heart Surgery
Official title: Effect of Inhaled Nitric Oxide on Major Adverse Events Requiring Intensive Life Support in Adults Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Phase III, Double-Blind, Multicenter, Randomized Controlled Trial (Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass, the NORISC Trial)
Run by Xijing Hospital · NCT06702553 · Data updated 2026-11-12
This study tests if inhaling nitric oxide during heart surgery can help adults recover better and avoid complications like kidney problems and breathing issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3650 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Status | Recruiting |
| Started | May 19, 2025 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2029 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT06702553 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are scheduled for elective cardiac or aortic surgery requiring cardiopulmonary bypass.
✕Probably not a fit
Patients who may not benefit include those requiring emergency surgery, those with severe pre-existing conditions, or those already on inhaled nitric oxide therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of inhaled nitric oxide therapy in adult patients undergoing elective cardiac surgery that requires cardiopulmonary bypass. The study aims to assess whether nitric oxide can reduce postoperative complications such as acute kidney injury and respiratory failure, which are common in cardiac surgery. Participants will be randomly assigned to receive either nitric oxide or standard care during their surgery. The trial seeks to determine the efficacy of this treatment in improving patient outcomes and reducing the need for intensive support post-surgery.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce complications and improve recovery times for patients undergoing cardiac surgery.
How similar studies have gone: Previous studies have shown mixed results with inhaled nitric oxide in cardiac surgery, indicating that while there are physiological benefits, translating these into improved clinical outcomes remains a challenge.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Elective cardiac or aortic surgery requiring CPB 3. Without history of previous open heart surgery. Exclusion Criteria: 1. Immediate emergency cardiac surgery; 2. Cardiac surgery that requires deep hypothermic circulatory arrest; 3. Planned cardiac surgery for congenital heart disease repair; 4. Planned for heart transplatation 5. Ongoing heart failure or low output syndrome already on intensive support (IABP, ECMO, left ventricular assist device such as impella, mechanical ventilation), left ventricular ejection fraction of \< 30% or comparable, equivalent preoperative conditions 6. Already accepted or currently on inhaled NO therapy or inhaled/aerosolized prostacyclin in the week prior to the enrollment; 7. Endstage kidney disease with estimated glomerular filtration rate (eGFR) \< 15 ml/min or already on renal replacement surgery. 8. Hemophilia A or B 9. Other terminal stage of chronic disease with life expectancy less than 1 year per evaluation and adjudication of the attending physicians.
Where it's running
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Xijing Hospital
Xi'an, Shaanxi, China Recruiting -
Massachusetts General Hospital, Department of Anesthesia, Critical Care and Pain Medicine
Boston, Massachusetts, United States Not yet recruiting -
Cardiology Research Institute, Tomsk National Research Medical Center
Tomsk, Russia Not yet recruiting
Study contacts
- Principal investigator: Chong Lei, M.D., & phd — Xijing Hospital
- Study coordinator: Chong Lei, M.D., & phd
- Email: crystalleichong@126.com
- Phone: 18629011362
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Integrated intraoperative hemodynamic monitoring during cardiac surgery with CPB
This pilot study tests a single-dashboard monitoring system to see if it can capture heart and tissue perfusion data during elective cardiac surgery with bypass in adults without changing patient care.
-
Impact of cardiopulmonary bypass on platelet lipids and bleeding after cardiac surgery
This study tests how CPB changes platelet lipid metabolism and procoagulant platelets to see if these changes relate to inflammation and bleeding after cardiac surgery.
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Transcutaneous auricular vagus nerve stimulation to prevent kidney injury after heart surgery
This trial tests whether applying a non-invasive ear stimulation (taVNS) around the time of elective heart surgery can help prevent acute kidney injury in adults undergoing cardiopulmonary bypass.
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Eurosets arterial and venous cannulas for cardiopulmonary bypass procedures
This trial will test Eurosets arterial and venous cannulas during cardiopulmonary bypass in adults having elective coronary or aortic valve surgery to see if they are as safe and work as well as Medtronic cannulas.
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Personalized lung volume optimization with PEEP titration for children after heart surgery or with severe respiratory failure
This trial tests whether a personalized lung volume optimization maneuver using PEEP titration can improve heart and lung function in children after cardiopulmonary bypass surgery or in those with severe respiratory failure at risk for ECMO.
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Autologous Cold-Stored Platelets for Complex Cardiac Surgery
This study tests whether using a patient’s own cold-stored platelets, donated 7–10 days before surgery, improves outcomes for adults undergoing complex cardiac procedures compared with standard allogeneic platelets.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.