AzTrials
AzTrials

Heart DiseasesNCT04058860

Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

A study testing NIRS monitoring, Cox monitoring and Sublingual microscopy in people with Heart Diseases, run by AHEPA University Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Heart Diseases
What is being tested?
NIRS monitoring, Cox monitoring and Sublingual microscopy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGreece
Study dates
1 Jun 2020to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Cardiothoracic Department, AHEPA University Hospital

    Thessaloniki

Other trials in Greece

About this study

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

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.

Read the 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

Conditions
Heart Diseases
Being tested
NIRS monitoring, Cox monitoring, Sublingual microscopy
Keywords
Microcirculation, Cardiac Surgery
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIRS monitoringDevice

    Cerebral and somatic near-infrared spectroscopy (rScO2) measurements

  • Cox monitoringDevice

    Cerebral autoregulation monitoring

  • Sublingual microscopyDevice

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

Study groups in NCT04058860
Study groupRoleWhat they receive
Study PatientsOtherPatients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications
Receives: Device: NIRS monitoring; Device: Cox monitoring; Device: Sublingual microscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of microcirculation

    Correlation of NIRS values with tissue microvascular activity

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

Secondary outcomes (4)

  1. Global perfusion

    Global perfusion using cerebral NIRS during extracorporeal circulation

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

  2. Cerebral autoregulation

    Calculation of cerebral oximetry index (COx)

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

  3. Goal-directed perfusion

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

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

  4. Somatic perfusion

    Peripheral tissue oxygenation as measured with somatic NIRS

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2019
  2. Study start1 Jun 2020
  3. Primary completion30 Nov 2021
  4. Study completion30 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04058860
Sponsor's protocol ID
AHEPA_CTS
Status last verified
Jul 2022
First submitted
12 Aug 2019
Last updated
25 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28692337

  • 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.

    PubMed 27013118

  • 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.

    PubMed 21178667

  • 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.

    PubMed 19372313

  • 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.

    PubMed 24161555

  • 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.

    PubMed 26658179

  • 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.

    PubMed 18603065

  • Antonitsis P, Argiriadou H, Gkiouliava A, Deliopoulos A, Mimikos S, Gilou S, Sarridou D, Voucharas C, Karapanagiotidis G, Anastasiadis K. The value of cerebral and somatic near-infrared spectroscopy within an integrated tissue perfusion monitoring strategy in cardiac surgery: A prospective pilot study. Perfusion. 2026 Jan;41(1):69-79. doi: 10.1177/02676591251340942. Epub 2025 May 8.

    PubMed 40338150

Questions about this trial

What is this clinical trial studying?

A study testing NIRS monitoring, Cox monitoring and Sublingual microscopy in people with Heart Diseases, run by AHEPA University Hospital at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of microcirculation (time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04058860, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.

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