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NCT05706545 Clinical Trial

Micro- and Macro-Circulation in Cardiac Surgery Patients

Cardiac Surgery Clinical Trial

— MiMaC  

Official title:
Micro- and Macro-Circulation in Cardiac Surgery Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05706545
Other study ID # MiMaC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date May 2025

Study information
Verified date October 2023
Source IRCCS Policlinico S. Donato
Contact Vlasta Bari, PhD
Phone +390252774381
Email vlasta.bari@grupposandonato.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date May 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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

Locations
Country Name City State
Italy IRCCS Policlinico San Donato San Donato Milanese Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers Statistical model assessment; time series variability analysis 24 months
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