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NCT Number: NCT07516938

Metabolic Profile and Tissue Perfusion in Patients Undergoing Open Heart Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation

The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion.

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Key information

Conditions

Aortic Valve Surgery Cardiac Surgery Coronary Artery Bypass Graft (CABG)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiothoracic Department, Artistotle University of Thessaloniki School of Medicine

Thessaloniki, Greece

About this study

The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion. Seventy patients undergoing coronary artery bypass grafting, aortic valve replacement or both procedures will be included in the study. Patients will be randomized in two groups: patients operated with the contemporary minimal invasive extracorporeal circulation (study group) versus patients operated with conventional extracorporeal circulation (control group). All patients will be operated according to the same anesthetic and perfusion protocol. During extracorporeal circulation, the following parameters will be recorded:

  • real-time tissue metabolism as indicated by oxygen delivery (DO2), oxygen consumption (VO2), oxygen extraction ratio (O2ER), CO2 consumption (VCO2), arterial and mixed venous saturation (SvO2)
  • blood lactate levels at defined intervals
  • real time cerebral oximetry (rSO2) using near-infrared spectroscopy (NIRS) The protective effect of minimal invasive extracorporeal circulation will be evidenced with comparative analysis of metabolic parameters between the two study groups. Real-time tissue metabolic parameters will be further associated with clinical data collected during hospital stay including postoperative morbidity and mortality, major adverse cardiac events, acute renal failure, re-intubation, need for prolonged mechanical ventilation (> 48 hours), re-operation, postoperative bleeding, need for blood product transfusion, ICU and total hospital stay.

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

  • need for emergency surgery
  • surgery on the thoracic aorta
  • severe co-morbities causing anemia, immunosuppression etc.
  • immunocompromised patients
  • inability to give informed consent

Treatment and study plan

Real-time tissue oximetry monitoring

Device

Real-time tissue metabolism as indicated by oxygen delivery (DO2), oxygen consumption (VO2), oxygen extraction ratio (O2ER), CO2 consumption (VCO2), arterial and mixed venous saturation (SvO2)

Primary outcomes

  1. Tissue hypoperfusion severity

    Time frame: During surgery, from initiation of cardiopulmonary bypass to weaning of cardiopulmonary bypass

    Area under the curve (AUC) where tissue oxygen delivery indexed (DO2i) remains below the critical value of 280 ml/min/m2.

Secondary outcomes

  1. Perfusion ratio derangement

    Time frame: During surgery from initiation of extracorporeal circulation to weaning of extracorporeal circulation.

    Incidence of patients that experience perfusion ratio (DO2i/VCO2i) < 5 during extracorporeal circulation.

  2. Cerebral hypoperfusion

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

    Incidence of patients that experience a reduction in cerebral near-infrared spectroscopy exceeding -20% from baseline during extracorporeal circulation.

  3. Overall mortality

    Time frame: From surgery to 30 days postoperatively

    Death from any cause

  4. Major adverse cardiac and cerebrovascular events

    Time frame: From surgery to 30 days postoperatively

    Composite incidense od postoperative stroke, myocardial infarction and need fr revascularization.

  5. Renal failure

    Time frame: From surgery to 30 days postoperatively

    Incidence of postoperative renal failure

  6. Re-intubation

    Time frame: From surgery to 30 days postoperatively

    Incidence of re-intubation

  7. Re-operation

    Time frame: From surgery to 30 days postoperatively

    Incidence of re-operation

  8. Postoperative bleeding

    Time frame: From surgery to 12 hours postoperatively

    Volume of postoperative blood loss

  9. Transfusion

    Time frame: Perioperatively

    Any blood product transfused

  10. ICU stay

    Time frame: From day of surgery to discharge from ICU, assessed up to 4 weeks postoperatively.

    Length of ICU stay

  11. Hospital stay

    Time frame: From day of surgery to discharge from hospital, assessed up to 4 weeks postoperatively.

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Study of Metabolic Profile and Tissue Perfusion in Patients Undergoing Open Heart Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation. Randomized Study

Acronym: MiECC MET

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 8, 2026
Registry last updated
Apr 8, 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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