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

NCT07516938 | Completed DMC

• 1 other identifier: MiECC MET
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

cardiopulmonary bypass; minimal invasive extracorporeal circulation; extracorporeal circulation; tissue oximetry; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• Tissue hypoperfusion severity

  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 Outcomes (11)

• Perfusion ratio derangement

  During surgery from initiation of extracorporeal circulation to weaning of extracorporeal circulation.

• Cerebral hypoperfusion

  During surgery, from initiation to weaning of extracorporeal circulation

• Overall mortality

  From surgery to 30 days postoperatively

• Major adverse cardiac and cerebrovascular events

  From surgery to 30 days postoperatively

• Renal failure

  From surgery to 30 days postoperatively

Study Arms (2)

Minimal Invasive Extracorporeal Circulation (MiECC)

EXPERIMENTAL

Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation

Device: Real-time tissue oximetry monitoring

Conventional Cardiopulmonary Bypass (cCPB)

ACTIVE COMPARATOR

Patients undergoing cardiac surgery with conventional cardiopulmonary bypass

Device: Real-time tissue oximetry monitoring

Interventions

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)

Conventional Cardiopulmonary Bypass (cCPB); Minimal Invasive Extracorporeal Circulation (MiECC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Cardiothoracic Department, Artistotle University of Thessaloniki School of Medicine

Thessaloniki, Greece

Location

Related Publications (4)

• Anastasiadis K, Antonitsis P, Asteriou C, Deliopoulos A, Argiriadou H. Modular minimally invasive extracorporeal circulation ensures perfusion safety and technical feasibility in cardiac surgery; a systematic review of the literature. Perfusion. 2022 Nov;37(8):852-862. doi: 10.1177/02676591211026514. Epub 2021 Jun 17.

  PMID: 34137323 BACKGROUND

• Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. Perfusion matters, and it will always matter in cardiac surgery. Perfusion. 2021 Oct;36(7):677-678. doi: 10.1177/02676591211025154. Epub 2021 Jun 19. No abstract available.

  PMID: 34148398 BACKGROUND

• Angelini GD, Reeves BC, Culliford LA, Maishman R, Rogers CA, Anastasiadis K, Antonitsis P, Argiriadou H, Carrel T, Keller D, Liebold A, Ashkaniani F, El-Essawi A, Breitenbach I, Lloyd C, Bennett M, Cale A, Gunaydin S, Gunertem E, Oueida F, Yassin IM, Serrick C, Murkin JM, Rao V, Moscarelli M, Condello I, Punjabi P, Rajakaruna C, Deliopoulos A, Bone D, Lansdown W, Moorjani N, Dennis S. Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS). Perfusion. 2025 Apr;40(3):730-741. doi: 10.1177/02676591241258054. Epub 2024 Jun 4.

  PMID: 38832503 BACKGROUND

• Antonitsis P, Argiriadou H, Gkiouliava A, Deliopoulos A, Mimikos S, Gilou S, Sarridou D, Voucharas C, Karapanagiotidis G, Anastasiadis K. The value of cerebral and somatic near-infrared spectroscopy within an integrated tissue perfusion monitoring strategy in cardiac surgery: A prospective pilot study. Perfusion. 2026 Jan;41(1):69-79. doi: 10.1177/02676591251340942. Epub 2025 May 8.

  PMID: 40338150 BACKGROUND

Study Officials

• Kyriakos Anastasiadis, MD, PhD, FETCS

  Aristotle University Of Thessaloniki

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiac Surgery

Model Details: All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: April 8, 2026
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)