Nosocomial Pneumonia Clinical Trial
Official title:
High-dose Inhaled NO Therapy for the pREvention of nosoCOmial Pneumonia After Cardiac Surgery Under caRDiopulmonary Bypass
NCT number | NCT06261827 |
Other study ID # | RECORD |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 20, 2024 |
Est. completion date | April 1, 2025 |
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | April 1, 2025 |
Est. primary completion date | February 20, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Cardiac surgery with CPB at current hospitalization. 2. Age > 18 years. 3. Signed informed consent Exclusion Criteria: 1. Emergency surgery. 2. Acute coronary syndrome 30 days before surgery. 3. Surgery for active infective endocarditis requiring antibiotic therapy. 4. Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, etc.). 5. Taking antibacterial drugs for 14 days preceding surgery 6. 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). 7. 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). 8. Continued mechanical ventilation. 9. Delirium. 10. Presence of tracheostomy. 11. Patient's participation in another clinical trial at the time of screening or within the previous 3 months. 12. Concomitant pulmonary disease with the need for respiratory support before surgery. 13. History of malignancy or other irreversible diseases/conditions with a 6- month mortality rate >50%. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Cardiology Research Institute Tomsk national Research Medical Center | Tomsk |
Lead Sponsor | Collaborator |
---|---|
Tomsk National Research Medical Center of the Russian Academy of Sciences |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of nosocomial pneumonia (percent) | The difference in the incidence of nosocomial pneumonia development (percent). | From the date of randomization until the date of discharge from hospital (from 2 to 4 weeks) | |
Secondary | Total leukocyte counts (10*9/L) | The difference in the levels of leukocytes (counts) | 7 days from the date of randomization | |
Secondary | Immature cell counts (percentage) | The difference between the levels of immature cells (counts) in the leukocyte formula | 7 days from the date of randomization | |
Secondary | C-reactive protein (CRP) level (mg/L) | The difference in the levels of C-reactive protein | 7 days from the date of randomization | |
Secondary | PCT (procalcitonin) test (ng/mL) | The difference in the levels of procalcitonin | 7 days from the date of randomization | |
Secondary | Presepsin levels (pg/mL) | The difference in the levels of presepsin | 7 days from the date of randomization | |
Secondary | Ferritin levels (ng/mL) | The difference in the levels of ferritin | 7 days from the date of randomization | |
Secondary | LDH (lactate dehydrogenase) levels (IU/L) | The difference in the levels of LDH | 7 days from the date of randomization | |
Secondary | Interleukin-6 (IL-6) levels (pg/mL) | The difference in the levels of IL-6 | 7 days from the date of randomization | |
Secondary | Interleukin-8 (IL-8) levels (pg/mL) | The difference in the levels of IL-8 | 7 days from the date of randomization | |
Secondary | Surfactant protein SP-D plasma levels (ng/mL) | The difference in the levels of SP-D | 7 days from the date of randomization | |
Secondary | sRAGE levels (pg/mL) | The difference in the levels of sRAGE | 7 days from the date of randomization | |
Secondary | endothelin-1 levels (pg/mL) | The difference in the levels of endothelin-1 | 7 days from the date of randomization | |
Secondary | Asymmetric dimethylarginine (ADMA) levels (ng/mL) | The difference in the levels of ADMA | 7 days from the date of randomization | |
Secondary | Vascular endothelial growth factor A (VEGF-A) levels (pg/mL) | The difference in the levels of VEGF-A | 7 days from the date of randomization | |
Secondary | Angiopoietin-1 levels (ng/mL) | The difference in the levels of angiopoietin-1 | 7 days from the date of randomization | |
Secondary | Angiopoietin-2 levels (ng/mL) | The difference in the levels of angiopoietin-2 | 7 days from the date of randomization | |
Secondary | S/F index (ratio) | The difference in S/F index | 7 days from the date of randomization | |
Secondary | Incidence of adverse lung ultrasound findings (percentage) | Adverse lung ultrasound findings are: increase in the volume of pleural effusion, appearance of consolidation, increase in the severity of interstitial involvement (increase in the number of B-lines) | 7 days from the date of randomization | |
Secondary | Six-minute walk test (6MWT) distance (meters) | Six-minute walk test (6MWT) distance (meters) is assessed. | 10 days from the date of randomization | |
Secondary | Lung vital capacity (L) | Lung vital capacity is assessed in liters (L) | 7 days from the date of randomization | |
Secondary | Forced vital capacity (L) | Forced vital capacity is assessed in liters (L) | 7 days from the date of randomization | |
Secondary | Forced expiratory volume (L/s) | Forced expiratory volume is assessed in liters per second (L/s) | 7 days from the date of randomization | |
Secondary | Peak expiratory flow (L/s) | Peak expiratory flow is assessed in liters per second (L/s) | 7 days from the date of randomization | |
Secondary | VE-minute ventilation (L/min) | VE-minute ventilation is assessed in liters per minute | 10 days from the date of randomization | |
Secondary | VT-tidal volume (L) | VT-tidal volume is assessed in liters | 10 days from the date of randomization | |
Secondary | VE/VO2 - ventilatory equivalents for oxygen (ratio) | VE/VO2 is assessed as ratio of VE to VO2 | 10 days from the date of randomization | |
Secondary | VE/V?O2 - ventilatory equivalent for carbon dioxide | VE/V?O2 is assessed as ratio of VE to VCO2 | 10 days from the date of randomization | |
Secondary | PetO2 - partial pressure of oxygen in exhaled air (mm Hg) | PetO2 is assessed in mm Hg | 10 days from the date of randomization | |
Secondary | PetCO2 - partial pressure of carbon dioxide in exhaled air (mmHg) | PetCO2 is assessed in mm Hg | 10 days from the date of randomization | |
Secondary | Exhaled NO levels (ppm) | The difference in the levels of exhaled NO before the start of the inhaled NO inhalations, upon its completion, 10 and 20 minutes after its completion. | Every day from the date of randomization until day 7 | |
Secondary | Systolic blood pressure (SBP) levels (mmHg) | The difference in the levels of SBP | Every day from the date of randomization until day 7 | |
Secondary | Diastolic blood pressure (DBP) levels (mmHg) | The difference in the levels of DBP | Every day from the date of randomization until day 7 | |
Secondary | Heart rate (HR) (bpm) | The difference in HR is assessed in beats per minute | Every day from the date of randomization until day 7 | |
Secondary | Respiratory rate (RR) (brpm) | The difference in RR is assessed in breaths per minute | Every day from the date of randomization until day 7 | |
Secondary | Saturation of peripheral oxygen (SpO2) levels (percentage) | The difference in SpO2 levels | Every day from the date of randomization until day 7 |
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