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

April 3, 2026 updated by: Polychronis Antonitsis, Aristotle University Of Thessaloniki

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece
        • Cardiothoracic Department, Artistotle University of Thessaloniki School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minimal Invasive Extracorporeal Circulation (MiECC)
Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation
Device: Real-time tissue oximetry monitoring
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)
Active Comparator: Conventional Cardiopulmonary Bypass (cCPB)
Patients undergoing cardiac surgery with conventional cardiopulmonary bypass
Device: Real-time tissue oximetry monitoring
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During surgery, from initiation of cardiopulmonary bypass to weaning of cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During surgery from initiation of extracorporeal circulation to weaning of extracorporeal circulation.
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.
During surgery, from initiation to weaning of extracorporeal circulation
Overall mortality
Time Frame: From surgery to 30 days postoperatively
Death from any cause
From surgery to 30 days postoperatively
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.
From surgery to 30 days postoperatively
Renal failure
Time Frame: From surgery to 30 days postoperatively
Incidence of postoperative renal failure
From surgery to 30 days postoperatively
Re-intubation
Time Frame: From surgery to 30 days postoperatively
Incidence of re-intubation
From surgery to 30 days postoperatively
Re-operation
Time Frame: From surgery to 30 days postoperatively
Incidence of re-operation
From surgery to 30 days postoperatively
Postoperative bleeding
Time Frame: From surgery to 12 hours postoperatively
Volume of postoperative blood loss
From surgery to 12 hours postoperatively
Transfusion
Time Frame: Perioperatively
Any blood product transfused
Perioperatively
ICU stay
Time Frame: From day of surgery to discharge from ICU, assessed up to 4 weeks postoperatively.
Length of ICU stay
From day of surgery to discharge from ICU, assessed up to 4 weeks postoperatively.
Hospital stay
Time Frame: From day of surgery to discharge from hospital, assessed up to 4 weeks postoperatively.
Length of hospital stay
From day of surgery to discharge from hospital, assessed up to 4 weeks postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Study Chair: Kyriakos Anastasiadis, MD, PhD, FETCS, Aristotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

August 12, 2025

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MiECC MET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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