High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia (NCT06170372) | Clinical Trial Compass
RecruitingNot Applicable
High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia
Russia200 participantsStarted 2024-01-15
Plain-language summary
This is a multicenter, prospective randomized controlled trial. At least 2 but no more than 5 centers are expected to participate in the study.
The primary objective is to test the hypothesis that the addition of high-dose inhaled nitric oxide therapy to standard treatment has a positive effect on the clinical course of pneumonia and the structure and function of cardiopulmonary system.
Number of participants: 200, including the subproject NO-PNEUMONIA-CAP - 100 CAP participants, the subproject NO-PNEUMONIA-NP - 100 NP participants.
Number of groups: 4 Inhalation of iNO at a dose of 200 ppm for 30 minutes under the control of methemoglobin level (no more than 5%) three times a day if the patient is allocated to the main group. The general course of iNO therapy will last until the pneumonia resolves, but no more than 7 days. Recording of vital signs and safety assessment will be carried out immediately before the initiation of NO therapy and every 15 minutes after its start (pulse, blood pressure, respiratory rate, SpO2, temperature, MetHb level).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. An established diagnosis of Nosocomial Pneumonia (NP) after cardiac surgery under cardiopulmonary bypass (CPB) or hospitalization for Community-acquired pneumonia (CAP).
✓. Spontaneous breathing.
✓. Age \> 18 years.
✓. Signed informed consent.
✓. Negative result of immunochromatographic Severe acute respiratory syndrome-related coronavirus 2 rapid antigen test on the day of diagnosis of pneumonia.
✓. acute fever at the onset of the disease (t° \> 38.0°C);
✕. Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, infective endocarditis etc.).
What they're measuring
1
Pneumonia resolution time (days)
Timeframe: 30 days from the date of randomization
Trial details
NCT IDNCT06170372
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences