Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment3650 (estimated)
SponsorXijing Hospital
Academic / other
Locations3 sites (Boston, Massachusetts and 2 other locations)
StatusRecruiting
StartedMay 19, 2025
Main results expectedMarch 31, 2028
Study endsMarch 31, 2029
Registry record updatedMay 29, 2026
Trial IDNCT06702553 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.