Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery
Primary Purpose
Heart Diseases
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
NIRS monitoring
Cox monitoring
Sublingual microscopy
Sponsored by

About this trial
This is an interventional diagnostic trial for Heart Diseases focused on measuring Microcirculation, Cardiac Surgery
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
Sites / Locations
- Cardiothoracic Department, AHEPA University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study Patients
Arm Description
Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications
Outcomes
Primary Outcome Measures
Evaluation of microcirculation
Correlation of NIRS values with tissue microvascular activity
Secondary Outcome Measures
Global perfusion
Global perfusion using cerebral NIRS during extracorporeal circulation
Cerebral autoregulation
Calculation of cerebral oximetry index (COx)
Goal-directed perfusion
Correlation of goal-directed perfusion with microvascular capillary density during extracorporeal circulation
Somatic perfusion
Peripheral tissue oxygenation as measured with somatic NIRS
Full Information
NCT ID
NCT04058860
First Posted
August 12, 2019
Last Updated
July 22, 2022
Sponsor
AHEPA University Hospital
Collaborators
Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT04058860
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AHEPA University Hospital
Collaborators
Medtronic - MITG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
Keywords
Microcirculation, Cardiac Surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Patients
Arm Type
Other
Arm Description
Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications
Intervention Type
Device
Intervention Name(s)
NIRS monitoring
Intervention Description
Cerebral and somatic near-infrared spectroscopy (rScO2) measurements
Intervention Type
Device
Intervention Name(s)
Cox monitoring
Intervention Description
Cerebral autoregulation monitoring
Intervention Type
Device
Intervention Name(s)
Sublingual microscopy
Intervention Description
Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging
Primary Outcome Measure Information:
Title
Evaluation of microcirculation
Description
Correlation of NIRS values with tissue microvascular activity
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary Outcome Measure Information:
Title
Global perfusion
Description
Global perfusion using cerebral NIRS during extracorporeal circulation
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Title
Cerebral autoregulation
Description
Calculation of cerebral oximetry index (COx)
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Title
Goal-directed perfusion
Description
Correlation of goal-directed perfusion with microvascular capillary density during extracorporeal circulation
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Title
Somatic perfusion
Description
Peripheral tissue oxygenation as measured with somatic NIRS
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyriakos Anastasiadis, MD, PhD
Organizational Affiliation
Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helena Argiriadou, MD, PhD
Organizational Affiliation
Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiothoracic Department, AHEPA University Hospital
City
Thessaloniki
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28692337
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.
Results Reference
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PubMed Identifier
27013118
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.
Results Reference
background
PubMed Identifier
21178667
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.
Results Reference
background
PubMed Identifier
19372313
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.
Results Reference
background
PubMed Identifier
24161555
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.
Results Reference
background
PubMed Identifier
26658179
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.
Results Reference
background
PubMed Identifier
18603065
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.
Results Reference
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Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery
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