Status:
COMPLETED
High-dose Inhaled NO Therapy for the Prevention of Nosocomial Pneumonia After Cardiac Surgery With CPB
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions:
Nosocomial Pneumonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pati...
Detailed Description
NOSOCOMIAL PNEUMONIA AFTER CARDIAC SURGERY WITH CADIOPULMONARY BYPASS. Nosocomial pneumonia (NP) is one of the most common complications of cardiac surgery with cardiopulmonary bypass (CPB), its frequ...
Eligibility Criteria
Inclusion
- 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
- 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).
- 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).
- Continued mechanical ventilation.
- Delirium.
- Presence of tracheostomy.
- Patient's participation in another clinical trial at the time of screening or within the previous 3 months.
- Concomitant pulmonary disease with the need for respiratory support before surgery.
- History of malignancy or other irreversible diseases/conditions with a 6-month mortality rate \>50%.
- Presence of HIV infection.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06162455
Start Date
November 17 2023
End Date
February 6 2024
Last Update
March 8 2024
Active Locations (1)
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1
Cardiology Research Institute Tomsk National Research Medical Center
Tomsk, Select..., Russia, 634012