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

NCT05479188 | Completed DMC

• 1 other identifier: AUS_CTS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.

Conditions

Coronary Artery Disease; Aortic Valve Stenosis; Mitral Disease

Keywords

extracorporeal circulation; Minimal Invasive Extracorporeal Circulation; cardiopulmonary bypass; cerebral oximetry; microcirculation; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (3)

• Proportion of perfused vessels assessed with sublingual microscopy

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

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

• Total vessel density assessed with sublingual microscopy

  Total vessel density (TVD) assessed with sublingual microscopy.

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

• Perfused vessel density assessed with sublingual microscopy

  Perfused vessel density (PVD) assessed with sublingual microscopy.

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

Secondary Outcomes (3)

• Cerebral oximetry

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

• Peripheral tissue oximetry

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

• Cox index assessed with near-infrared spectroscopy

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

Study Arms (2)

Minimal Invasive Extracorporeal Circulation (MiECC)

ACTIVE COMPARATOR

Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation.

Device: Cerebral oximetry; Device: Peripheral oximetry; Device: Cerebral autoregulation; Device: Sublingual microscopy

Conventional cardiopulmonary Bypass (cCPB)

ACTIVE COMPARATOR

Patients undergoing cardiac surgery with conventional cardiopulmonary bypass.

Device: Cerebral oximetry; Device: Peripheral oximetry; Device: Cerebral autoregulation; Device: Sublingual microscopy

Interventions

Cerebral oximetry DEVICE

Cerebral oximetry monitoring with near-infrared spectroscopy.

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

Peripheral oximetry DEVICE

Tissue perfusion monitoring with somatic near-infrared spectroscopy.

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

Cerebral autoregulation DEVICE

Cerebral autoregulation monitoring with COx.

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

Sublingual microscopy DEVICE

Evaluation of microcirculation with sublingual microscopy.

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

Eligibility Criteria

• Age: 18 Years - 85 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:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Cardiothoracic Department, AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

Related Publications (5)

• Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. A multidisciplinary perioperative strategy for attaining "more physiologic" cardiac surgery. Perfusion. 2017 Sep;32(6):446-453. doi: 10.1177/0267659117700488. Epub 2017 Mar 10.

  PMID: 28692337 BACKGROUND

• Yuruk K, Bezemer R, Euser M, Milstein DM, de Geus HH, Scholten EW, de Mol BA, Ince C. The effects of conventional extracorporeal circulation versus miniaturized extracorporeal circulation on microcirculation during cardiopulmonary bypass-assisted coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):364-70. doi: 10.1093/icvts/ivs271. Epub 2012 Jun 14.

  PMID: 22700685 BACKGROUND

• Donndorf P, Kuhn F, Vollmar B, Rosner J, Liebold A, Gierer P, Steinhoff G, Kaminski A. Comparing microvascular alterations during minimal extracorporeal circulation and conventional cardiopulmonary bypass in coronary artery bypass graft surgery: a prospective, randomized study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):677-83. doi: 10.1016/j.jtcvs.2012.05.037. Epub 2012 Jun 12.

  PMID: 22698563 BACKGROUND

• Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.

  PMID: 24161555 BACKGROUND

• Kara A, Akin S, Ince C. The response of the microcirculation to cardiac surgery. Curr Opin Anaesthesiol. 2016 Feb;29(1):85-93. doi: 10.1097/ACO.0000000000000280.

  PMID: 26658179 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Stenosis; Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyriakos Anastasiadis, Prof.

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

• Helena Argiriadou, Assoc. Prof.

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiac Surgery, Head of Cardiothoracic Department

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: July 22, 2022
• First Posted: July 29, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)