High-dose Inhaled NO Therapy for the Prevention of Nosocomial Pneumonia After Cardiac Surgery Wit… (NCT06162455) | Clinical Trial Compass
CompletedNot Applicable
High-dose Inhaled NO Therapy for the Prevention of Nosocomial Pneumonia After Cardiac Surgery With CPB
Russia74 participantsStarted 2023-11-17
Plain-language summary
The primary aim of this single-center, prospective, randomized, controlled, pilot study is to test the hypothesis that inhalation of NO 200 ppm prevents the development of nosocomial pneumonia in patients at risk after cardiac surgery with CPB. The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk National Research Medical Center for elective surgery with CPB.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Cardiac surgery with CPB at current hospitalization.
. Age \> 18 years.
. Signed informed consent.
. The presence of at least one risk factor for the development of postoperative NP (CPB time ≥ 96 minutes and/or mechanical ventilation ≥ 14 hours and/or atrial fibrillation before surgery).
Exclusion criteria
. Emergency surgery.
. Acute coronary syndrome 30 days before surgery.
. Surgery for active infective endocarditis requiring antibiotic therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of nosocomial pneumonia (percent)
Timeframe: From the date of randomization until the date of discharge from hospital (from 2 to 4 weeks)
Trial details
NCT IDNCT06162455
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
. Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, etc.).
. Taking antibacterial drugs for 14 days preceding surgery.
. Other complications of the postoperative period (pneumothorax requiring pleural drainage, perioperative myocardial infarction accompanied by pulmonary edema, shock of any etiology during the current hospitalization).
. Potentially dialysis-dependent stage 2 and higher acute kidney injury (according to KDIGO) in the early postoperative period (the criteria for potentially dialysis-dependent acute kidney injury will include patients with stage 2 acute kidney injury and: oliguria against the background of normo-hypervolemia and resistance to loop diuretics and/or oliguria against the background of conducting infusion therapy due to hypovolemia and resistance to loop diuretics).