Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

NCT04058860 | Completed

• 1 other identifier: AHEPA_CTS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Keywords

Microcirculation; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Evaluation of microcirculation

  Correlation of NIRS values with tissue microvascular activity

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

Secondary Outcomes (4)

• Global perfusion

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

• Cerebral autoregulation

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

• Goal-directed perfusion

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

• Somatic perfusion

  During surgery, from induction of anesthesia to weaning of extracorporeal circulation

Study Arms (1)

Study Patients

OTHER

Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications

Device: NIRS monitoring; Device: Cox monitoring; Device: Sublingual microscopy

Interventions

NIRS monitoring DEVICE

Cerebral and somatic near-infrared spectroscopy (rScO2) measurements

Study Patients

Cox monitoring DEVICE

Cerebral autoregulation monitoring

Study Patients

Sublingual microscopy DEVICE

Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging

Study Patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHEPA University Hospital: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Cardiothoracic Department, AHEPA University Hospital

Thessaloniki, Greece

Location

Related 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.

  PMID: 28692337 BACKGROUND

• 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.

  PMID: 27013118 BACKGROUND

• 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.

  PMID: 21178667 BACKGROUND

• 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.

  PMID: 19372313 BACKGROUND

• 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.

  PMID: 24161555 BACKGROUND

• 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.

  PMID: 26658179 BACKGROUND

• 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.

  PMID: 18603065 BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Kyriakos Anastasiadis, MD, PhD

  Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Helena Argiriadou, MD, PhD

  Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiac Surgery

Model Details: Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 16, 2019
• Study Start: June 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)