Micro- and Macro-Circulation in Cardiac Surgery Patients

NCT ID: NCT05706545

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2027-01-31

Study Completion Date

2027-05-31

Brief Summary

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The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening, death).

The state of sublingual microcirculation, of peripheral microcirculation and cardiovascular control will be assessed in 100 patients undergoing cardiac surgery during general anesthesia before the intervention and at the end of the intervention at the arrival in post-surgery ICU by means of signal processing techniques.

The extracted markers will be used to assess a statistical prediction model of major morbidities.

Detailed Description

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Conditions

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Cardiac Surgery Coronary Artery Bypass Graft Surgical Aortic Valve Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Acquisition of cardiovascular signals and microcirculation sidestream darkfield images

ECG, arterial pressure and peripheral flow velocity via a percutaneous laser doppler will be acquired together with images of the sublingual microcirculation detected with sidestream darkfield images microscope

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* age \>18 yrs
* indication for a cardiac surgery intervention
* spontaneous sinus rhythm
* informed consent

Exclusion Criteria

* know autonomic nervous systems pathologies or dysfunctions
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Vlasta Bari

Assistant Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico San Donato

San Donato Milanese, Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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MiMaC

Identifier Type: -

Identifier Source: org_study_id

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