Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

• Sponsor: AHEPA University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04058860
• Collaborator: Medtronic - MITG (Industry)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 18
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases	Device: NIRS monitoring; Device: Cox monitoring; Device: Sublingual microscopy	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indicationsPatients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery; Challenging Near-infrared Spectroscopy With Microvascular Density and Metabolic Parameters
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Nov 30, 2021
• Actual Study Completion Date: Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Study Patients Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications	Device: NIRS monitoring; Cerebral and somatic near-infrared spectroscopy (rScO2) measurements; Device: Cox monitoring; Cerebral autoregulation monitoring; Device: Sublingual microscopy; Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging

Outcome Measures

Primary Outcome Measures

1. Evaluation of microcirculation [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Correlation of NIRS values with tissue microvascular activity

Secondary Outcome Measures

1. Global perfusion [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Global perfusion using cerebral NIRS during extracorporeal circulation

2. Cerebral autoregulation [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Calculation of cerebral oximetry index (COx)

3. Goal-directed perfusion [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Correlation of goal-directed perfusion with microvascular capillary density during extracorporeal circulation

4. Somatic perfusion [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Peripheral tissue oxygenation as measured with somatic NIRS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiothoracic Department, AHEPA University Hospital	Thessaloniki		Greece

Sponsors and Collaborators

• AHEPA University Hospital
• Medtronic - MITG

Investigators

• Principal Investigator: Kyriakos Anastasiadis, MD, PhD, Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece
• Principal Investigator: Helena Argiriadou, MD, PhD, Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Kyriakos Anastasiadis, Professor of Cardiac Surgery, AHEPA University Hospital
• ClinicalTrials.gov Identifier: NCT04058860
• Other Study ID Numbers: AHEPA_CTS
• First Posted: Aug 16, 2019
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kyriakos Anastasiadis, Professor of Cardiac Surgery, AHEPA University Hospital: Microcirculation; Cardiac Surgery
• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of Jul 25, 2022