High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia

• Status: Recruiting
• Trial end date: 2027-01-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

1. An established diagnosis of Nosocomial Pneumonia (NP) after cardiac surgery under cardiopulmonary bypass (CPB) or hospitalization for Community-acquired pneumonia (CAP).

2. Spontaneous breathing.

3. Age > 18 years.

4. Signed informed consent.

5. Negative result of immunochromatographic Severe acute respiratory syndrome-related coronavirus 2 rapid antigen test on the day of diagnosis of pneumonia.

Diagnostic criteria for NP The diagnosis of NP is considered established when the number of points on the

Clinical Pulmonary Infection Score (CPIS) is greater than 6:

Diagnostic criteria for CAP:

Radiologically confirmed focal pulmonary opacity and at least 2 clinical symptoms and signs of the following:

1. acute fever at the onset of the disease (t° > 38.0°C);

2. cough with sputum;

3. physical signs (crepitus/fine rales, bronchial breathing, shortening of percussion sound);

4. leukocytosis > 10x109/l and/or left shift (> 10%)

Exclusion Criteria:

1. 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.).

2. Mechanical ventilation

3. Presence of tracheostomy

4. Patient's participation in another clinical trial at the time of screening or within the previous 3 months.

5. Concomitant pulmonary disease with the need for respiratory support before the development of pneumonia.

6. History of malignancy or other irreversible diseases/conditions with a life expectancy of less than 1 year.

7. Presence of HIV infection