nctId: NCT06261827 id: RECORD briefTitle: High-dose Inhaled NO Therapy for the pREvenvention of NP After Cardiac Surgery Under CPB overallStatus: RECRUITING date: 2024-02-20 date: 2025-02-20 date: 2025-04-01 date: 2024-02-15 date: 2024-03-07 name: Tomsk National Research Medical Center of the Russian Academy of Sciences class: OTHER briefSummary: 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. conditions: Nosocomial Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Sham treatment name: 200-ppm NO measure: Incidence of nosocomial pneumonia (percent) measure: Total leukocyte counts (10*9/L) measure: Immature cell counts (percentage) measure: C-reactive protein (CRP) level (mg/L) measure: PCT (procalcitonin) test (ng/mL) measure: Presepsin levels (pg/mL) measure: Ferritin levels (ng/mL) measure: LDH (lactate dehydrogenase) levels (IU/L) measure: Interleukin-6 (IL-6) levels (pg/mL) measure: Interleukin-8 (IL-8) levels (pg/mL) measure: Surfactant protein SP-D plasma levels (ng/mL) measure: sRAGE levels (pg/mL) measure: endothelin-1 levels (pg/mL) measure: Asymmetric dimethylarginine (ADMA) levels (ng/mL) measure: Vascular endothelial growth factor A (VEGF-A) levels (pg/mL) measure: Angiopoietin-1 levels (ng/mL) measure: Angiopoietin-2 levels (ng/mL) measure: S/F index (ratio) measure: Incidence of adverse lung ultrasound findings (percentage) measure: Six-minute walk test (6MWT) distance (meters) measure: Lung vital capacity (L) measure: Forced vital capacity (L) measure: Forced expiratory volume (L/s) measure: Peak expiratory flow (L/s) measure: VE-minute ventilation (L/min) measure: VT-tidal volume (L) measure: VE/VO2 - ventilatory equivalents for oxygen (ratio) measure: VE/VСO2 - ventilatory equivalent for carbon dioxide measure: PetO2 - partial pressure of oxygen in exhaled air (mm Hg) measure: PetCO2 - partial pressure of carbon dioxide in exhaled air (mmHg) measure: Exhaled NO levels (ppm) measure: Systolic blood pressure (SBP) levels (mmHg) measure: Diastolic blood pressure (DBP) levels (mmHg) measure: Heart rate (HR) (bpm) measure: Respiratory rate (RR) (brpm) measure: Saturation of peripheral oxygen (SpO2) levels (percentage) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardiology Research Institute Tomsk national Research Medical Center status: RECRUITING city: Tomsk country: Russian Federation name: Nikolay O. Kamenshchikov role: CONTACT phone: +79138183657 email: nikolajkamenof@mail.ru name: Tatiana P Kalashnikova role: CONTACT phone: +79138141664 email: kalashnikova-t@mail.ru lat: 56.49771 lon: 84.97437 hasResults: False