NCT06391866

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 17, 2024

Last Update Submit

April 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Estimating biochemical parameters

    1 hour

  • Estimating biochemical parameters

    6 hours

  • Estimating biochemical parameters Third biochemical examination

    1 hour

  • Estimating biochemical parameters

    6 hours

Study Arms (3)

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

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

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.

Interventions

extracorporeal circulation during cardiosurgical operation

Experimental group 1Experimental group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient undergoing cardiac surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Europainclinics

Košice, 04011, Slovakia

RECRUITING

Related Publications (1)

  • Kocan L, Sudzina R, Kocanova H, Zavacka M, Pobehova J, Rybar D, Dudova M, Ferencik M, Vaskova J. Early Cognitive Outcomes After Carotid Endarterectomy in Asymptomatic Stenosis: A Pilot Study. Cureus. 2025 Nov 11;17(11):e96559. doi: 10.7759/cureus.96559. eCollection 2025 Nov.

MeSH Terms

Conditions

Neuroinflammatory Diseases

Interventions

Extracorporeal Circulation

Condition Hierarchy (Ancestors)

Nervous System DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Ladislav Kočan, MD, PhD, FIPP

CONTACT

Janka Vašková, prof. Dr. PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 30, 2024

Study Start

April 30, 2024

Primary Completion

April 30, 2025

Study Completion

December 31, 2025

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations