Neuroinflammation/Oxidative Stress/Cardiac Surgery (NEuOX-postSURg)

Assessing Neuroinflammation and Oxidative Stress After Cardiac Surgery: Unveiling Molecular Dynamics and Clinical Outcomes

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

Study Overview

• Status: Recruiting
• Conditions: Neuroinflammation
• Intervention / Treatment: Other: extracorporeal circulation

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Ladislav Kočan, MD, PhD, FIPP; Phone Number: +421557891110; Email: europainclinicsstudy@gmail.com
• Study Contact Backup: Name: Janka Vaskova, Prof. Dr. PhD.; Email: janka.vaskova@upjs.sk

Study Locations

• Slovakia
  • Košice, Slovakia, 04011
    • Recruiting
    • Europainclinics
    • Contact: Ladislav Kočan, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing cardiac surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group 1; 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.	Other: extracorporeal circulation; extracorporeal circulation during cardiosurgical operation
Experimental group 2; Patients undergoing scheduled cardiac procedures, including coronary artery bypass grafting (CABG) or valve replacement, requiring extracorporeal circulation (ECC) for more than 60 minutes.	Other: extracorporeal circulation; extracorporeal circulation during cardiosurgical operation
Control group: Patients scheduled for cardiac surgical procedures such as coronary artery bypass grafting (CABG) without extracorporeal circulation, and for carotid endarterectomy in neurologically asymptomatic patients prior to the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and type of early complications after surgery	Estimating of postoperative complications	1 month
Number and type of postoperative complications	Estimating of postoperative complications	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimating biochemical parameters	Pro-inflammatory interleukins parameters (e.g. IL-8, IL-6, MIP-1a, MMP-2, MMP-9, SIRT 1, SIRT 2)	1 hour
Estimating biochemical parameters	Pro-inflammatory interleukins	6 hours
Estimating biochemical parameters Third biochemical examination	Antioxidative enzymes	1 hour
Estimating biochemical parameters	Antioxidative enzymes	6 hours

Collaborators and Investigators

• Sponsor: Europainclinics z.ú.
• Collaborators: East Slovak Institute for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Inflammation; Neuroinflammatory Diseases
• Other Study ID Numbers: NeuOX-postSurg Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After completing data collection, the data will be made available to the ethical committees of interested institutions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No