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