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Completed

NCT Number: NCT05479188

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

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiothoracic Department, AHEPA University Hospital

Thessaloniki, 54636, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing undergoing open heart surgery with accepted indications under extracorporeal circulation

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

Treatment and study plan

Sublingual microscopy

Device

Evaluation of microcirculation with sublingual microscopy.

Primary outcomes

  1. Proportion of perfused vessels assessed with sublingual microscopy

    Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation

    Proportion of perfused vessels (PPV) assessed with sublingual microscopy.

  2. Total vascular density assessed with sublingual microscopy

    Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation

    Total vascular density (TVD) assessed with sublingual microscopy.

  3. Perfused vessel density assessed with sublingual microscopy

    Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation

    Perfused vessel density (PVD) assessed with sublingual microscopy.

  4. Microvascular Flow Index (MFI)

    Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation

    Microvascular Flow Index (MFI) assessed with sublingual microscopy

Secondary outcomes

  1. Peak lactate levels

    Time frame: During surgery from induction to weaning of cardiopulmonary bypass

    Peak lactate levels during cardiopulmonary bypass in mmol/l

  2. Mean arterial pressure

    Time frame: During surgery from induction to weaning of cardiopulmonary bypass

    Mean arterial pressure during cardiopulmonary bypass

  3. Overall mortality rate

    Time frame: From surgery to 30 days postoperatively

    Incidence of death from any cause

  4. Rate of preoperative myocardial infarction

    Time frame: From surgery to 30 days postoperatively

    Incidence of perioperative myocardial infarction

  5. Rate of postoperative stroke

    Time frame: From surgery to 30 days postoperatively

    Incidence of patients that experience a postperative stroke verified with CT brain scan

  6. Rate of postoperative revascularization

    Time frame: From surgery to 30 days postoperatively

    Incidence of patients who require postoperative revascularization

  7. Rate of postoperative renal failure

    Time frame: From surgery to 30 days postoperatively

    Incidence of patients that experience postoperative acute kidney injury according too AKIN criteria

  8. Rate of re-intubation

    Time frame: From surgery to 30 days postoperatively

    Incidence of patients that required re-intubation

  9. Rate of re-operation

    Time frame: From surgery to 30 days postoperatively

    Incidence of patients that required a re-operation

  10. Volume of postoperative bleeding

    Time frame: From ICU admission to 12 hours postoperatively

    Volume of postoperative bleeding (ml)

  11. Rate of blood product transfusion

    Time frame: Postoperatively up to 30 days

    Incidence of any blood product transfusion

  12. Length of ICU stay

    Time frame: Perioperatively, up to 4 weeks after surgery

    Total length of ICU stay in hours

  13. Length of hospital stay

    Time frame: Perioperatively, from the day of operation up to 4 weeks after surgery

    Length of hospital stay in days

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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