Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

Heart Diseases Clinical Trial

Official title:

Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery; Challenging Near-infrared Spectroscopy With Microvascular Density and Metabolic Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058860
• Other study ID #: AHEPA_CTS
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2022
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Device:
• NIRS monitoring
Cerebral and somatic near-infrared spectroscopy (rScO2) measurements
• Cox monitoring
Cerebral autoregulation monitoring
• Sublingual microscopy
Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AHEPA University Hospital	Medtronic - MITG

Country where clinical trial is conducted

Greece, 

References & Publications (7)

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

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. — View Citation

den Uil CA, Lagrand WK, Spronk PE, van Domburg RT, Hofland J, Lüthen 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. — 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. Review. — 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

Murkin JM. Cerebral oximetry: monitoring the brain as the index organ. Anesthesiology. 2011 Jan;114(1):12-3. doi: 10.1097/ALN.0b013e3181fef5d2. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of microcirculation	Correlation of NIRS values with tissue microvascular activity	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary	Global perfusion	Global perfusion using cerebral NIRS during extracorporeal circulation	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary	Cerebral autoregulation	Calculation of cerebral oximetry index (COx)	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary	Goal-directed perfusion	Correlation of goal-directed perfusion with microvascular capillary density during extracorporeal circulation	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary	Somatic perfusion	Peripheral tissue oxygenation as measured with somatic NIRS	During surgery, from induction of anesthesia to weaning of extracorporeal circulation