Clinical trial NCT04058860: Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery
Official title: Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery; Challenging Near-infrared Spectroscopy With Microvascular Density and Metabolic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: Microcirculation
Cardiac Surgery
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2019-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery under extracorporeal circulation. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.

Detailed description: The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery under 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 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

Eligibility criteria: Inclusion Criteria:

* patients aged \> 18 and \< 85 years with coronary artery disease and/or aortic valve disease undergoing open heart surgery with accepted indications

Exclusion Criteria:

* patients undergoing emergency surgery
* patients in preoperative cardiogenic shock with evidence of tissue malperfusion
* patients \> 85 years of age
* patients with severe peripheral vascular disease

Primary outcomes:
measure: Evaluation of microcirculation
timeFrame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary outcomes:
measure: Global perfusion
timeFrame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
measure: Cerebral autoregulation
timeFrame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
measure: Goal-directed perfusion
timeFrame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
measure: Somatic perfusion
timeFrame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Cardiothoracic Department, AHEPA University Hospital
Study officials:
affiliation: Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece
name: Kyriakos Anastasiadis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece
name: Helena Argiriadou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Anastasiadis K, Antonitsis P, Ranucci M, Murkin J. Minimally Invasive Extracorporeal Circulation (MiECC): Towards a More Physiologic Perfusion. J Cardiothorac Vasc Anesth. 2016 Apr;30(2):280-1. doi: 10.1053/j.jvca.2016.01.018. Epub 2016 Jan 13. No abstract available.
citation: Murkin JM. Cerebral oximetry: monitoring the brain as the index organ. Anesthesiology. 2011 Jan;114(1):12-3. doi: 10.1097/ALN.0b013e3181fef5d2. No abstract available.
citation: Murphy GS, Hessel EA 2nd, Groom RC. Optimal perfusion during cardiopulmonary bypass: an evidence-based approach. Anesth Analg. 2009 May;108(5):1394-417. doi: 10.1213/ane.0b013e3181875e2e.
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.
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.
citation: den Uil CA, Lagrand WK, Spronk PE, van Domburg RT, Hofland J, Luthen C, Brugts JJ, van der Ent M, Simoons ML. Impaired sublingual microvascular perfusion during surgery with cardiopulmonary bypass: a pilot study. J Thorac Cardiovasc Surg. 2008 Jul;136(1):129-34. doi: 10.1016/j.jtcvs.2007.10.046. Epub 2008 May 2.