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

NCT06170372 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-10

No results posted yet for this study

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).

Conditions

  • Nosocomial Pneumonia
  • Community-acquired Pneumonia

Interventions

DRUG

200 ppm Nitric Oxide

NO will be supplemented at 200-ppm concentration 3 times a day for 30 min until the pneumonia resolves, but no more than 7 days

DRUG

Sham treatment

Oxygen-air mixture without NO 3 times a day for 30 min until the pneumonia resolves, but no more than 7 days

Sponsors & Collaborators

  • Tomsk National Research Medical Center of the Russian Academy of Sciences

    lead OTHER

Principal Investigators

  • Tatiana P Kalashnikova, MD, PhD · Cardiology Research Institute, Tomsk National Research Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2026-01-15
Completion
2027-01-15

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06170372 on ClinicalTrials.gov