Using Nitric Oxide to Improve Recovery in Heart Surgery

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)

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
• Enrollment: 3650 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 3 sites (Boston, Massachusetts and 2 other locations)
• Trial ID: NCT06702553 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Boston, Massachusetts and 2 other locations

• Massachusetts General Hospital, Department of Anesthesia, Critical Care and Pain Medicine — Boston, Massachusetts, United States (Not_yet_recruiting)
• Xijing Hospital — Xi'an, Shaanxi, China (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

Conditions Nitric Oxide; Cardiac Surgery; Cardiopulmonary Bypass; Adult Patients Undergoing Cardiovascular Surgery With Cardiopulmonary Bypass; cardiopulmonary bypass; major adverse events; cardiac surgery; complications