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

NCT06477757 | Not Yet Recruiting

• 1 other identifier: J7-50129
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiac Surgery; Minimally invasive extracorporeal circulation; Cardiopulmonary bypass; Oxidative Stress; Systemic Inflammatory Response Syndrome; Oxidative stress biomarkers; Malondialdehyde; Endocan

Outcome Measures

Primary Outcomes (1)

• Oxidative stress biomarker levels

  Oxidative stress biomarker levels will be analyzed from blood samples collected at predetermined time-frames.

  From enrollment until discharge, assessed up to 100 weeks.

Secondary Outcomes (2)

• Incidence of postoperative atrial fibrillation

  From enrollment until discharge, assessed up to 100 weeks.

• Incidence of postoperative acute kidney failure

  From enrollment until discharge, assessed up to 100 weeks.

Study Arms (2)

Conventional Extracorporeal Circulation Arm (CCPB Arm)

ACTIVE COMPARATOR

Patients randomized into this group will be undergoing arrested-heart coronary artery bypass grafting with the use of conventional extracorporeal circulation.

Procedure: Conventional Extracorporeal Circulation

Minimally Invasive Extracorporeal Circulation Arm (MiECC Arm)

EXPERIMENTAL

Patients randomized into this group will be undergoing arrested-heart coronary artery bypass grafting with the use of minimally invasive extracorporeal circulation.

Procedure: Minimally Invasive Extracorporeal Circulation

Interventions

Minimally Invasive Extracorporeal Circulation PROCEDURE

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

Minimally Invasive Extracorporeal Circulation Arm (MiECC Arm)

Conventional Extracorporeal Circulation PROCEDURE

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

Conventional Extracorporeal Circulation Arm (CCPB Arm)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective isolated coronary artery bypass grafting (CABG) with the use of cardio-pulmonary bypass (CPB) through median sternotomy with central cannulation

You may not qualify if:

• 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.
• \- 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.

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (1)

UMC Maribor

Maribor, Slovenia

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Rene Petrovic, MD

  UMC Maribor

  PRINCIPAL INVESTIGATOR

• Petra Kotnik, PhD

  University of Maribor

  PRINCIPAL INVESTIGATOR

• Miha Antonic, MD, PhD

  UMC Maribor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rene Petrovic, MD

CONTACT

+38640556570; rene.petrovic@gmail.com

Miha Antonic, MD, PhD

CONTACT

miha.antonic@guest.arnes.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomisation will be done in blocks beforehand. As the patients will be enlisted, the group they were assigned to, will be revealed.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups of patients, each undergoing open-heart surgery with a different type of extracorporeal circulation.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: June 27, 2024
• Study Start: July 29, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the study, approximately in 2026.

Locations

SL (1)