Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06170372

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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