High-dose Inhaled NO Therapy for the Prevention of Nosocomial Pneumonia After Cardiac Surgery With CPB

NCT06162455 | Completed

• 1 other identifier: RECORD Pilot
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nosocomial Pneumonia

Outcome Measures

Primary Outcomes (1)

• Incidence of nosocomial pneumonia (percent)

  Differences between groups in the incidence of nosocomial pneumonia development (percent).

  From the date of randomization until the date of discharge from hospital (from 2 to 4 weeks)

Secondary Outcomes (6)

• Level of fever (˚C)

  7 days

• Level of leukocytes (counts)

  7 days

• Level of C-reactive protein (mg/L)

  7 days

• S/F index (ratio)

  7 days

• Incidence of sepsis and septic shock (percent)

  7 days

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Drug: Sham treatment

200 ppm

EXPERIMENTAL

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

Drug: 200- ppm NO

Interventions

Sham treatment DRUG

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

Also known as: Oxygen-Air Mixture

Control group

200- ppm NO DRUG

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

Also known as: Nitric Oxide

200 ppm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac surgery with CPB at current hospitalization.
• Age \> 18 years.
• Signed informed consent.
• 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).

You may not qualify if:

• Emergency surgery.
• Acute coronary syndrome 30 days before surgery.
• Surgery for active infective endocarditis requiring antibiotic therapy.
• Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, etc.).
• Taking antibacterial drugs for 14 days preceding surgery.
• 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).
• 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).
• Continued mechanical ventilation.
• Delirium.
• Presence of tracheostomy.
• Patient's participation in another clinical trial at the time of screening or within the previous 3 months.
• Concomitant pulmonary disease with the need for respiratory support before surgery.
• History of malignancy or other irreversible diseases/conditions with a 6-month mortality rate \>50%.
• Presence of HIV infection.

Sponsors & Collaborators

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

Study Sites (1)

Cardiology Research Institute Tomsk National Research Medical Center

Tomsk, Select..., 634012, Russia

Location

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Nikolay O. Kamenshchikov

  Cardiology Research Institute, Tomsk National Research Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 8, 2023
• Study Start: November 17, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 6, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)