High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.).
Mechanical ventilation
Presence of tracheostomy
Patient's participation in another clinical trial at the time of screening or within the previous 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
200 ppm Nitric Oxide
DrugNO will be supplemented at 200-ppm concentration 3 times a day for 30 min until the pneumonia resolves, but no more than 7 days
Sham treatment
DrugOxygen-air mixture without NO 3 times a day for 30 min until the pneumonia resolves, but no more than 7 days
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: Main group with nosocomial pneumoniaExperimental treatment 1 intervention
Group B: Control group with nosocomial pneumoniaActive comparator 1 intervention
Group C: Main group with community acquired pneumoniaExperimental treatment 1 intervention
Group D: Control group with community acquired pneumoniaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pneumonia resolution time (days)
Pneumonia resolution time is assessed as number of days from the date of randomization till pneumonia resolution.
Time frame
30 days from the date of randomizationSecondary outcomes
1
Fever higher than 37˚C (days)
Fever is assessed in number of days when the level of fever is higher than 37˚C
Time frame
30 days from the date of randomization2
Total leukocyte counts (10*9/L)
The difference in the levels of leukocytes (counts) is assessed between the time points corresponding to the start of therapy and 72 hours after therapy begins in the study groups
Time frame
72 hours from the start of therapy3
Immature cell counts (percentage)
The difference between the levels of immature cells (counts) in the leukocyte formula is assessed between the time points corresponding to the start of therapy and 72 hours after therapy begins in the study groups
Time frame
72 hours from the start of therapy4
Pneumonia resolution-associated change in total leukocyte counts (10*9/L)
The difference in the levels of leukocytes (counts) is assessed between the time points corresponding to the start of therapy and the day of pneumonia resolution. In case pneumonia does not resolve within 30 days, the change is assessed between the date of randomization and day 30.
Time frame
30 days from the date of randomizationSponsors and contacts
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Source ClinicalTrials.gov