Neuroinflammation/Oxidative Stress/Cardiac Surgery

Recruiting

• Conditions: Neuroinflammation
• Interventions: Other: extracorporeal circulation

• Registration Number: NCT06391866
• Lead Sponsor: Europainclinics z.ú.

Brief Summary

The prospective observational study delves into the complex relationship between neuroinflammation and oxidative stress in post-cardiac surgery complications, focusing on postoperative cognitive dysfunction.

Detailed Description

The prospective observational study meticulously examines the interplay between neuroinflammation and oxidative stress in the realm of post-cardiac surgery complications, specifically targeting postoperative cognitive dysfunction. Its primary objective is to comprehensively assess the sustained influence of these intricate processes on cognitive function and overall well-being, extending beyond the immediate aftermath of surgery. The research endeavors to probe deeply into the molecular mechanisms and clinical ramifications associated with neuroinflammation and oxidative stress, centering on their pivotal role in shaping the onset and trajectory of postoperative cognitive dysfunction.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study Start: 2024-04-30
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-04-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Undergoing cardiosurgical operation
• Absence of previous neurological disease
• Signed informed consent document

Exclusion Criteria

• Presence of neoplasms
• Neurological Disease
• Refusal to participate in the clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group 1	extracorporeal circulation	Patients scheduled for elective cardiac surgery, such as coronary artery bypass grafting (CABG) or valve replacement, involving extracorporeal circulation (ECC) with a duration less than 60 minutes.
Experimental group 2	extracorporeal circulation	Patients undergoing scheduled cardiac procedures, including coronary artery bypass grafting (CABG) or valve replacement, requiring extracorporeal circulation (ECC) for more than 60 minutes.

Primary Outcome Measures

Name	Time	Method
Number and type of early complications after surgery	1 month	Estimating of postoperative complications
Number and type of postoperative complications	6 months	Estimating of postoperative complications

Secondary Outcome Measures

Name	Time	Method
Estimating biochemical parameters Third biochemical examination	1 hour	Antioxidative enzymes
Estimating biochemical parameters	6 hours	Antioxidative enzymes

Trial Locations

Locations (1)

Europainclinics; 🇸🇰 Košice, Slovakia