Neuroinflammation/Oxidative Stress/Cardiac Surgery

Neuroinflammation Clinical Trial

— NEuOX-postSURg  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391866
• Other study ID #: NeuOX-postSurg Trial
• Status: Recruiting
• Start date: April 30, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Europainclinics z.ú.
• Contact: Ladislav Kocan, MD, PhD, FIPP
• Phone: +421557891110
• Email: europainclinicsstudy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2025
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuroinflammation

Intervention

Other:
• extracorporeal circulation
extracorporeal circulation during cardiosurgical operation

Locations

Country	Name	City	State
Slovakia	Europainclinics	Košice

Sponsors (2)

Lead Sponsor	Collaborator
Europainclinics z.ú.	East Slovak Institute for Cardiovascular Diseases

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and type of early complications after surgery	Estimating of postoperative complications	1 month
Primary	Number and type of postoperative complications	Estimating of postoperative complications	6 months
Secondary	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
Secondary	Estimating biochemical parameters	Pro-inflammatory interleukins	6 hours
Secondary	Estimating biochemical parameters Third biochemical examination	Antioxidative enzymes	1 hour
Secondary	Estimating biochemical parameters	Antioxidative enzymes	6 hours