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Completed

NCT Number: NCT04058860

Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiothoracic Department, AHEPA University Hospital

Thessaloniki, Greece

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIRS monitoring

Device

Cerebral and somatic near-infrared spectroscopy (rScO2) measurements

Cox monitoring

Device

Cerebral autoregulation monitoring

Sublingual microscopy

Device

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

Primary outcomes

  1. Evaluation of microcirculation

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

    Correlation of NIRS values with tissue microvascular activity

Secondary outcomes

  1. Global perfusion

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

    Global perfusion using cerebral NIRS during extracorporeal circulation

  2. Cerebral autoregulation

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

    Calculation of cerebral oximetry index (COx)

  3. Goal-directed perfusion

    Time frame: 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

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

    Peripheral tissue oxygenation as measured with somatic NIRS

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2019
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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