Clinical trial
High-dose Inhaled NO Therapy for the Prevention of Nosocomial Pneumonia After Cardiac Surgery With Cardiopulmonary Bypass
Name
RECORD Pilot
Description
The primary aim of this single-center, prospective, randomized, controlled, pilot 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 with 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.
Trial arms
Trial start
2023-11-17
Estimated PCD
2024-01-15
Trial end
2024-02-06
Status
Completed
Treatment
Sham treatment
Oxygen-air mixture without NO after extubation after surgery for 5 days 2 times a day for 30 min
Arms:
Control group
Other names:
Oxygen-Air Mixture
200- ppm NO
NO will be supplemented at 200-ppm concentration after surgery for 5 days 2 times a day for 30 min
Arms:
200 ppm
Other names:
Nitric Oxide
Size
74
Primary endpoint
Incidence of nosocomial pneumonia (percent)
From the date of randomization until the date of discharge from hospital (from 2 to 4 weeks)
Eligibility criteria
Inclusion Criteria:
1. Cardiac surgery with CPB at current hospitalization.
2. Age \> 18 years.
3. Signed informed consent.
4. The presence of at least one risk factor for the development of postoperative NP (CPB time ≥ 96 minutes and/or mechanical ventilation ≥ 14 hours and/or atrial fibrillation before surgery).
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%.
14. Presence of HIV infection.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 74, 'type': 'ACTUAL'}}
Updated at
2024-03-08
1 organization
2 products
1 indication
Product
Sham treatmentIndication
nosocomial pneumoniaProduct
200- ppm NO