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High-dose Inhaled NO Therapy for the pREvenvention of NP After Cardiac Surgery Under CPB

NCT06261827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-12-09

No results posted yet for this study

Summary

The primary aim of this single-center, prospective, randomized, controlled, study is to test the hypothesis that inhalation of NO 200 ppm prevents the development of nosocomial pneumonia in patients at risk after cardiac surgery under CPB. The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk National Research Medical Center for elective surgery with CPB.

Conditions

  • Nosocomial Pneumonia

Interventions

DRUG

Sham treatment

Oxygen-air mixture without NO after extubation after surgery for 5 days 2 times a day for 30 min

DRUG

200-ppm NO

NO will be supplemented at 200-ppm concentration after surgery for 5 days 2 times a day for 30 min

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Nikolay O. Kamenshchikov · Cardiology Research Institute, Tomsk National Research Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2025-05-20
Completion
2025-10-01

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 NCT06261827 on ClinicalTrials.gov