Inhaled nitric oxide therapy to prevent pneumonia after heart surgery

High-dose Inhaled NO Therapy for the pREvention of nosoCOmial Pneumonia After Cardiac Surgery Under caRDiopulmonary Bypass

This study is testing if inhaling a special gas can help prevent pneumonia in patients who are having heart surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (Academic / other)
• Locations: 1 site (Tomsk)
• Trial ID: NCT06261827 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of inhaling 200 ppm of nitric oxide (NO) in preventing nosocomial pneumonia in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). It is a single-center, prospective, randomized, controlled study conducted at the Cardiology Research Institute of Tomsk National Research Medical Center. The study will include patients who are at risk for pneumonia post-surgery and will compare the outcomes of those receiving NO treatment to those receiving a sham treatment. The research adheres to approved medical standards and does not involve any unregistered procedures.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who are scheduled for elective cardiac surgery involving cardiopulmonary bypass.

Not a fit: Patients undergoing emergency surgery or those with active infections or other serious complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of pneumonia and improve recovery outcomes for patients after cardiac surgery.

How similar studies have performed: While similar approaches have been explored, this specific application of high-dose inhaled NO therapy for pneumonia prevention in cardiac surgery is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Cardiac surgery with CPB at current hospitalization.
2. Age \> 18 years.
3. Signed informed consent

Exclusion Criteria:

1. Emergency surgery.
2. Acute coronary syndrome 30 days before surgery.
3. Surgery for active infective endocarditis requiring antibiotic therapy.
4. Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, etc.).
5. Taking antibacterial drugs for 14 days preceding surgery
6. Other complications of the postoperative period (pneumothorax requiring pleural drainage, perioperative myocardial infarction accompanied by pulmonary edema, shock of any etiology during the current hospitalization).
7. Potentially dialysis-dependent stage 2 and higher acute kidney injury (according to KDIGO) in the early postoperative period (the criteria for potentially dialysis-dependent acute kidney injury will include patients with stage 2 acute kidney injury and: oliguria against the background of normo-hypervolemia and resistance to loop diuretics and/ or oliguria against the background of conducting infusion therapy due to hypovolemia and resistance to loop diuretics).
8. Continued mechanical ventilation.
9. Delirium.
10. Presence of tracheostomy.
11. Patient's participation in another clinical trial at the time of screening or within the previous 3 months.
12. Concomitant pulmonary disease with the need for respiratory support before surgery.
13. History of malignancy or other irreversible diseases/conditions with a 6- month mortality rate \>50%.

Where this trial is running

Tomsk

• Cardiology Research Institute Tomsk national Research Medical Center — Tomsk, Russian Federation (Recruiting)

Study contacts

• Principal investigator: Nikolay O. Kamenshchikov — Cardiology Research Institute, Tomsk National Research Medical Center
• Study coordinator: Nikolay O. Kamenshchikov

Conditions Nosocomial Pneumonia