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

Study acronym: NO PNEUMONIA
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Enrollment closed, study ongoing
    • Site details revised
    v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Minor Secondary endpoints: details revised at 1 of 29 entriesv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06170372
Lead Sponsor Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions
(from sponsor)
Nosocomial Pneumonia, Community-acquired Pneumonia
Related terms Community-Acquired Pneumonia, Healthcare-Associated Pneumonia
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov