Actively Recruiting
High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia
Led by Tomsk National Research Medical Center of the Russian Academy of Sciences · Updated on 2025-04-10
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Nosocomial Pneumonia after cardiac surgery with cardiopulmonary bypass or Community-acquired pneumonia
- Spontaneous breathing without mechanical ventilation
- Age over 18 years
- Signed informed consent
- Negative rapid antigen test for Severe acute respiratory syndrome-related coronavirus 2 on the day pneumonia is diagnosed
You will not qualify if you...
- Infection in another location such as surgical site, urinary tract, bloodstream, peritonitis, or endocarditis
- Use of mechanical ventilation
- Presence of tracheostomy
- Participation in another clinical trial currently or within the past 3 months
- Existing lung disease requiring respiratory support before pneumonia
- History of cancer or other irreversible diseases with life expectancy less than 1 year
- Presence of HIV infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cardiology Research Institute Tomsk National Research Medical Center
Tomsk, Select..., Russia, 634012
Actively Recruiting
Research Team
T
Tatiana P. Kalashnikova, MD, PhD
CONTACT
N
Nikolay O. Kamenshchikov, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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