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

RecruitingPhase 3Ages 18 Years - anyAllXijing Hospital
NCT06702553 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Cardiac surgery is a procedure that is commonly performed worldwide. Despite these technological advances, cardiac surgery remains a high-risk surgery. Among post-operative complications, acute kidney injury, respiratory failure, myocardial infarction, and stroke as well as cognitive dysfunction are significant causes of mortality in patients undergoing and following cardiac surgery. Inhaled nitric oxide (NO) therapy as a selective pulmonary vasodilator in cardiac surgery has been one of the most significant pharmacological advances in managing pulmonary hemodynamics and life threatening right ventricular dysfunction and failure. In addition, newer applications show greater promise of inhaled NO as a therapy in the area of cardiac surgery associated acute kidney injury and ischemia reperfusion. However, this remarkable expectation to inhaled NO has experienced a roller-coaster ride with

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📋 Eligibility rules (as published)
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.
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What it tests

  • Nitric Oxide Gas
  • Standard Care Arm
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Where

3 sites
Massachusetts General Hospital, Department of Anesthesia, Critical Care and Pain Medicine
Boston, United States
Xijing Hospital
Xi'an, China
Cardiology Research Institute, Tomsk National Research Medical Center
Tomsk, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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