Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation

Last updated: April 4, 2026
Sponsor: Aristotle University Of Thessaloniki
Overall Status: Completed

Phase

N/A

Condition

Coronary Artery Disease

Vascular Diseases

Cardiovascular Disease

Treatment

Peripheral oximetry

Cerebral autoregulation

Cerebral oximetry

Clinical Study ID

NCT05479188
AUS_CTS
  • Ages 18-85
  • All Genders

Study Summary

The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients undergoing undergoing open heart surgery with accepted indications underextracorporeal circulation

Exclusion

Exclusion Criteria:

  • patients undergoing emergency surgery

  • patients in preoperative cardiogenic shock with evidence of tissue malperfusion

  • patients with severe peripheral vascular disease

  • patients unable to give informed consent

Study Design

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: Peripheral oximetry
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
December 31, 2023

Study Description

Background: Cardiac surgery is performed with the use of extracorporeal circulation which triggers a systemic inflammatory response leading to end-organ dysfunction. Contemporary minimal invasive extracorporeal circulation represents an evolution of the conventional extracorporeal circulation that reduces systemic inflammatory response and improves clinical outcome in large studies. A potential explanation includes preservation of tissue microcirculation with minimal invasive extracorporeal circulation as the underlying pathophysiologic mechanism.

Aim: The aim of the present study is to detect differences in tissue microcirculation during cardiopulmonary bypass with minimal (study group) versus conventional (control group) in patients undergoing open heart surgery.

Study type: This is a randomized comparative study. Patients: The study group consists of sixty patients scheduled for elective open-heart surgery (coronary artery bypass grafting, aortic valve replacement of combined procedure) at the Cardiothoracic Department School of Medicine Aristotle University of Thessaloniki.

Intervention: Patients included in the study will be randomly assigned in two groups with a computer-generated algorithm. Study group will undergo cardiac surgery with minimal invasive extracorporeal circulation while control group will be operated with the use of conventional extracorporeal circulation.

Protocol: In both groups tissue microcirculation will be assessed with the use of a specifically designed second generation hand-held video monitoring device which uses sidestream dark field (SDF) imaging placed at the sublingual mucosa. Microcirculatory assessments will be performed at the following time-points: before induction of anesthesia (baseline - T0), after induction of general anesthesia (T1), after initiation of cardiopulmonary bypass (T2) and immediately after weaning cardiopulmonary bypass (T3).

Outcomes: The composite primary outcome of the study consists of obtained differences in the main microcirculatory quantitative variables (Proportion of Perfused Vessels, Microvascular Flow Index, Total Vascular Density, Perfused Vessel Density) during defined time points. Secondary outcomes consist of differences in postoperative 30-days morbidity and mortality.

Connect with a study center

  • Cardiothoracic Department, AHEPA University Hospital

    Thessaloniki, 54636
    Greece

    Site Not Available

  • Cardiothoracic Department, AHEPA University Hospital

    Thessaloníki, 54636
    Greece

    Site Not Available

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