Study of Microcirculation During Extracorporeal Circulation in Cardiac

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Heart Diseases

Clinical Trial Details

NCT number	NCT04058860
Study type	Interventional
Source	AHEPA University Hospital
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2020
Completion date	November 30, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms