Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass

Launched by XIJING HOSPITAL · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of inhaled nitric oxide (iNO) during cardiac surgery to see if it can help reduce serious complications after surgery. These complications can include heart failure, kidney problems, and other major health issues. The researchers believe that using iNO may improve recovery for patients undergoing elective heart surgery that requires a special machine called cardiopulmonary bypass (CPB), which helps keep the blood flowing while the heart is being operated on. The goal is to see if iNO can lower the rate of serious events, like death or major health issues, from 20% to 16% within 30 days after surgery.

To be eligible for this trial, participants must be at least 18 years old and scheduled for elective cardiac or aortic surgery that requires CPB. They should not have had any previous open-heart surgeries or be in immediate emergency situations. Participants can expect to receive a treatment that may help improve their recovery, and they will be closely monitored throughout the study. This research aims to provide strong evidence that could change guidelines for using iNO in cardiac surgeries, potentially benefiting many patients in the future.

Gender

ALL

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.