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

Summary

The goal of our research project is to measure and compare oxidative stress markers, and systemic inflammatory response in patients undergoing open heart surgery with either conventional or minimally invasive extracorporeal circulation as well as develop pharmacokinetic profiles of different oxidative stress markers for further research on inflammatory response after open heart surgery. The main questions our study aims to answer are :

* Does the type of extracorporeal circulation affect the levels of different oxidative stress markers?
* Can preoperative and postoperative oxidative stress marker levels be of prognostic values?
* Do preoperative and postoperative oxidative stress markers correlate with the clinical outcomes in patients?

Researchers will compare the effect of conventional and minimally invasive extracorporeal circulation on clinical outcomes, oxidative stress marker levels, and systemic inflammatory response.

Participants will be randomised into two groups (one undergoing arrested-heart surgery with the use of conventional extracorporeal circulation, and the second group undergoing arrested-heart surgery with the use of minimally invasive extracorporeal circulation) and laboratory data, oxidative stress markers, and clinical data will be collected until discharge.

Conditions

• Oxidative Stress
• Systemic Inflammatory Response Syndrome
• Extracorporeal Circulation; Complications

Interventions

PROCEDURE

Minimally Invasive Extracorporeal Circulation

Clinical outcomes, oxidative stress marker levels comparison in patients undergoing open-heart surgery with minimally invasive extracorporeal circulation.

PROCEDURE

Conventional Extracorporeal Circulation

Clinical outcomes, oxidative stress marker levels comparison in patients undergoing open-heart surgery with either conventional extracorporeal circulation.

Sponsors & Collaborators

• University Medical Centre Maribor

  lead OTHER

Principal Investigators

• Rene Petrovic, MD · UMC Maribor

• Petra Kotnik, PhD · University of Maribor

• Miha Antonic, MD, PhD · UMC Maribor

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-29

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• Slovenia

Study Locations