High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia
Status:
Recruiting
Trial end date:
2027-01-15
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences