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Search / Trial NCT06477757

Inflammatory Response and Oxidative Stress in Cardiac Surgery: Min. Invasive vs. Conventional Extracorporeal Circulation

Launched by UNIVERSITY MEDICAL CENTRE MARIBOR · Jun 25, 2024

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Cardiac Surgery Minimally Invasive Extracorporeal Circulation Cardiopulmonary Bypass Oxidative Stress Systemic Inflammatory Response Syndrome Oxidative Stress Biomarkers Malondialdehyde Endocan

ClinConnect Summary

This clinical trial is designed to study how two different methods of heart surgery—conventional extracorporeal circulation and minimally invasive extracorporeal circulation—affect patients' bodies during and after the procedure. Researchers want to understand if the type of surgery influences the levels of oxidative stress (which is the damage caused by free radicals in the body) and the body's inflammatory response. They will look at how these factors relate to patient outcomes, such as recovery and overall health, before and after surgery.

To participate in this study, you will need to be between 65 and 74 years old and undergoing elective coronary artery bypass surgery using a heart-lung machine. If you are pregnant, have had previous heart surgery, or are having emergency surgery, you won't be eligible. Participants will be randomly assigned to one of the two surgery methods, and the research team will collect various health information and blood samples until you are discharged. This study aims to improve our understanding of how these surgical methods affect recovery, which could lead to better care for heart surgery patients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients undergoing elective isolated coronary artery bypass grafting (CABG) with the use of cardio-pulmonary bypass (CPB) through median sternotomy with central cannulation
  • Exclusion Criteria Before Enrollment:
  • refusal to participate in the study,
  • pregnant women,
  • patients with previous cardiac surgery (i.e., redo surgery),
  • emergency surgery,
  • patients with known allergy to any drugs used in the study protocol except cefazolin.
  • Exclusion Criteria After Enrollment:
  • - Patients in whom intraoperative transesophageal echocardiogram (TEE) would show an atrial septal defect, where additional procedures would be needed intraoperatively or a conversion from MiECC to conventional extracorporeal circulation would be needed.

About University Medical Centre Maribor

University Medical Centre Maribor is a leading healthcare institution in Slovenia, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a prominent academic center, it integrates cutting-edge research with clinical practice, fostering collaboration among healthcare professionals, researchers, and patients. The institution is committed to enhancing medical knowledge and treatment options across various specialties, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on patient safety and well-being, University Medical Centre Maribor plays a pivotal role in contributing to the global medical community through its rigorous clinical research initiatives.

Locations

Maribor, , Slovenia

Patients applied

0 patients applied

Trial Officials

Rene Petrovic, MD

Principal Investigator

UMC Maribor

Petra Kotnik, PhD

Principal Investigator

University of Maribor

Miha Antonic, MD, PhD

Principal Investigator

UMC Maribor

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported