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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity Medical Centre Maribor

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

refusal to participate in the study,

pregnant women,

patients with previous cardiac surgery (i.e., redo surgery),

emergency surgery,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minimally Invasive Extracorporeal Circulation

    Procedure/Surgery

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

  • Conventional Extracorporeal Circulation

    Procedure/Surgery

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Conventional Extracorporeal Circulation Arm (CCPB Arm)Active comparator 1 intervention
Group B: Minimally Invasive Extracorporeal Circulation Arm (MiECC Arm)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Oxidative stress biomarker levels

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

Time frame
From enrollment until discharge, assessed up to 100 weeks.

Secondary outcomes

1

Incidence of postoperative atrial fibrillation

Atrial fibrillation will be monitored by continuous telemetry following cardiac surgery, until discharge.

Time frame
From enrollment until discharge, assessed up to 100 weeks.
2

Incidence of postoperative acute kidney failure

Kidney function will be monitored by measuring urine secretion and glomerular filtration rate at predetermined time frames, and evaluated according to Kidney Disease: Improving Global Outcomes (KDIGO) system.

Time frame
From enrollment until discharge, assessed up to 100 weeks.

Other outcomes

Sponsors and contacts

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