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NCT06702553 · ClinicalTrials.gov registry record · Phase 3
Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass
A Phase 3 study of Cardiac Surgery and Cardiopulmonary Bypass, sponsored by Xijing Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 3,650
- Enrollment target
- 3
- Study locations
NCT06702553 is a Phase 3 study of Cardiac Surgery and Cardiopulmonary Bypass that is actively recruiting participants, run by Xijing Hospital. The registered enrollment target is 3,650 participants, above the 553-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (560% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT06702553, a Phase 3 study of Cardiac Surgery and Cardiopulmonary Bypass, is actively recruiting participants, sponsored by Xijing Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,650 participants
- Enrollment target
- 3
- Study locations
Study Summary
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 mortalit
Conditions Studied
Interventions
- DRUG Nitric Oxide Gas
- DRUG Standard Care Arm
Study Locations (3)
Massachusetts
- Massachusetts General Hospital, Department of Anesthesia, Critical Care and Pain Medicine - Boston
Shaanxi
- Xijing Hospital - Xi'an
Other
- Cardiology Research Institute, Tomsk National Research Medical Center - Tomsk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,650 participants |
| Start Date | 2025-05-19 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06702553
The ClinicalTrials.gov registry entry for NCT06702553 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 3,650 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 553-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (560% higher). The listed sponsor is Xijing Hospital, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Cardiac Surgery appearing as the primary indexed condition, and to 2 interventions - of which Nitric Oxide Gas is the first listed.
NCT06702553 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Massachusetts, Shaanxi, Other.
Frequently Asked Questions
What is clinical trial NCT06702553 about?
NCT06702553 is a clinical study titled "Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass". 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...
What is the current status of trial NCT06702553?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 3,650 participants. The study started on 2025-05-19. Estimated completion is 2029-03-31.
What conditions does trial NCT06702553 study?
This clinical trial studies the following conditions: Cardiac Surgery, Cardiopulmonary Bypass, Nitric Oxide, Adult Patients Undergoing Cardiovascular Surgery With Cardiopulmonary Bypass.
What interventions are being tested in trial NCT06702553?
The interventions under investigation include: Nitric Oxide Gas (DRUG), Standard Care Arm (DRUG).
Who is sponsoring clinical trial NCT06702553?
This trial is sponsored by Xijing Hospital, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06702553 being conducted?
This trial has 3 study locations across Massachusetts, Shaanxi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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