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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05479188
Other study ID # AUS_CTS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date December 31, 2023

Study information

Verified date January 2023
Source Aristotle University Of Thessaloniki
Contact Polychronis Antonitsis, Assoc. Prof.
Phone +30 2310994871
Email antonits@auth.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation. Microcirculatory changes during cardiac surgery have been investigated mainly during coronary procedures using the conventional extracorporeal circulation.There is no single study in the literature investigating microcirculatory alterations using a perioperative strategy of "physiologic" perfusion. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level. All patients will follow the same anaesthetic and perfusion protocol. The patients will be randomized to two arms: 1. Patients operated with Minimal Invasive Extracorporeal Circulation (MiECC) 2. Patients operated with conventional cardiopulmonary bypass (cCPB) The protocol for the evaluation of microcirculation will be based on: - Cerebral near-infrared spectroscopy (rScO2) measurements (INVOS, Covidien-Medtronic Inc.). - NIRS-Based Cerebral Autoregulation Monitoring: Analog arterial blood pressure signals will be digitized and then processed with the digital NIRS signals using a personal computer and a special ICM software (University of Cambridge, Cambridge, UK). Monitoring cerebral autoregulation ensures adequate renal perfusion. Hence, brain can be used not just as a target but also as an index organ indicating adequacy of perfusion. - Somatic near-infrared spectroscopy (rSsO2) measurements (INVOS, Covidien-Medtronic Inc.). - Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging (MicroScan, Microvision Medical, Amsterdam, The Netherlands). All measurements will be performed at the following time points: T0: after induction of anaesthesia T1: after initiation of cardiopulmonary bypass T2: 10 minutes after cross- clamping the aorta T3: 10 minutes before removing the aortic cross-clamp T4: after weaning from extracorporeal circulation


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Device:
Cerebral oximetry
Cerebral oximetry monitoring with near-infrared spectroscopy.
Peripheral oximetry
Tissue perfusion monitoring with somatic near-infrared spectroscopy.
Cerebral autoregulation
Cerebral autoregulation monitoring with COx.
Sublingual microscopy
Evaluation of microcirculation with sublingual microscopy.

Locations

Country Name City State
Greece Cardiothoracic Department, AHEPA University Hospital Thessaloníki

Sponsors (1)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Cerebral oximetry Change in cerebral oxygen saturation during cardiac surgery assessed with near-infrared spectroscopy During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary Peripheral tissue oximetry Change in tissue perfusion during cardiac surgery assessed with near-infrared spectroscopy During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary Cox index assessed with near-infrared spectroscopy Evaluation of cerebral autoregulation during cardiac surgery with continuous monitoring of Cox index (ICM+ software, Cambridge, UK). During surgery, from induction of anesthesia to weaning of extracorporeal circulation
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