Nitric Oxide for Cardiac Surgery
(NORISC Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are already on inhaled nitric oxide therapy or inhaled/aerosolized prostacyclin, you cannot participate in the trial.
What data supports the effectiveness of the treatment Nitric Oxide for cardiac surgery?
Research suggests that nitric oxide can protect organs during cardiac surgery, especially the heart and kidneys, and may improve outcomes by acting as a safe and promising approach in managing patients during surgery. It has also shown benefits in improving oxygen levels in patients after heart surgery, potentially reducing complications and hospital stay.12345
Is nitric oxide safe for use in cardiac surgery?
Nitric oxide is considered safe for use in cardiac surgery, with side effects that are known, predictable, reversible, and relatively rare. It has been used in clinical practice at an acceptable cost, and further research supports its safety and potential benefits in managing patients during surgery.13567
How does the drug nitric oxide differ from other treatments for cardiac surgery?
Nitric oxide is unique in cardiac surgery because it acts as a protective agent for organs and tissues during the operation, especially benefiting the heart and kidneys. Unlike other treatments, it can be administered to supplement the body's own nitric oxide production, which may be reduced during surgery, and it is known for its predictable and reversible side effects.14589
What is the purpose of this trial?
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 high hopes and nearly universal demonstration of physiological benefits but disappointing translation of these benefits to harder clinical outcomes, like mortality. Most of our understanding on the iNO field in cardiac surgery stems from small observational or single center randomized trials, which failed to ascertain strong evidence base. As a consequence, there are only week clinical practice guidelines on the field and only European expert opinion for the use of iNO in routine and more specialized cardiac surgery. There is need for a large multicenter randomized controlled study to confirm the administration of iNO as an effective weapon for the battle against life threatening complication in high risk cardiac surgical patients.In a previous meta analysis with 27 studies included, we demonstrated that inhaled nitric oxide (NO) could reduce the duration of mechanical ventilation and reducing biomarkers of organ injury and clinical signs of organ dysfunction in cardiac surgery under cardiopulmonary bypass (CPB) , but had no significance in the ICU stay, hospital stay, and mortality. This may be attributed to the small sample size of the most included studies (of the 27 studies included, 20 studies with sample size less than 100) and heterogeneity in timing, dosage and duration of iNO administration. Well-designed, large-scale, multicenter clinical trials are needed to further explore the effect of iNO in improving postoperative prognosis in cardiovascular surgical patients.We are planning a large multicenter controlled randomized trial to demonstrate that inhaled nitric oxide can reduce composite outcome of death and Major Adverse Events (MAEs), including need for intensive supports due to heart failure, low cardiac output sydrome, or renal failure, respiratory failure, etc., and myocardial infarction, stroke, and sepsis at 30 days after surgery from 20% to 16% in patient undergoing cardiac surgery with cardiopulmonary bypass.If the hypothesis had been proved and validated, the results of this study can provide strong evidence for guidelines to facilitate the routine use of iNO in all cardiopulmonary bypass assisted cardiac procedures with 31,800 postoperative outcomes improved per year in US and in China.
Research Team
Chong Lei, M.D., & phd
Principal Investigator
Xijing Hospital
Eligibility Criteria
This trial is for adults (18+) needing elective cardiac or aortic surgery with cardiopulmonary bypass. It's not open to those who've had previous open-heart surgeries.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive inhaled nitric oxide during cardiopulmonary bypass and postoperatively to reduce major adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of major adverse events and mortality
Extended Follow-up
Long-term monitoring of mortality and quality of life outcomes
Treatment Details
Interventions
- Nitric Oxide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Xijing Hospital
Lead Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborator
Massachusetts General Hospital
Collaborator
Tianjin Chest Hospital, Tianjin, China
Collaborator
NORISC Trial Investigators
Collaborator
Nikolay O. Kamenshchikov., M.D., Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborator
Jiange Han, Tianjin Chest Hospital, Tianjin, China
Collaborator
Qingping Wu, Wuhan Union Hospital, Wuhan, China
Collaborator
Evgeniy Grigoriev, Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russian Federation
Collaborator
Vladimir Boboshko, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
Collaborator