High-dose Inhaled NO Therapy for the pREvenvention of NP After Cardiac Surgery Under CPB (NCT06261827) | Clinical Trial Compass
CompletedNot Applicable
High-dose Inhaled NO Therapy for the pREvenvention of NP After Cardiac Surgery Under CPB
Russia160 participantsStarted 2024-02-20
Plain-language summary
The primary aim of this single-center, prospective, randomized, controlled, 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 under 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 range18 Years
SexALL
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Inclusion criteria
✓. Cardiac surgery with CPB at current hospitalization.
✓. Age \> 18 years.
✓. Signed informed consent
Exclusion criteria
✕. Emergency surgery.
✕. Acute coronary syndrome 30 days before surgery.
✕. Surgery for active infective endocarditis requiring antibiotic therapy.
✕. 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).
✕
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 IDNCT06261827
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
. 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).