drugset / Trial / NCT04807413

Nitric Oxide During Cardiopulmonary Bypass in Adult Surgery

NCT04807413

Phase 3 Unknown 300 enrolled Rabin Medical Center
RandomizedParallel-groupSingle-blindPrevention

Summary

Inhaled nitric oxide is a widely accepted standard of care for pulmonary hypertension, and has been studied in the context of cardiac surgery. CPB during cardiac surgery induces systemic inflammatory response and ischemic-reperfusion injury of many organs. Nitric oxide added to the bypass circuit may have anti-inflammatory effect and has shown the potential to ameliorate organs' injury . There is evidence that the delivery of nitric oxide to the oxygenator gas flow during pediatric CPB is accompanied by a reduction in myocardial injury markers' levels in the postoperative period. In adults, NO supply to the CPB circuit during CABG exerted a cardioprotective effect and was associated with a lower level of inotropic support and cardio-specific blood markers . To our knowledge, this is the first trial to assess whether artificial nitric oxide supplementation to the CPB-system reduces the incidence of hypoxemia after cardiac surgery.

Timeline

Start
2021-08-14
Primary completion
2023-04
Completion
2023-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified 40 ppm Other

Indications

No indication recorded.