Micro- and Macro-Circulation in Cardiac Surgery Patients

NCT05706545 | Suspended

• 1 other identifier: MiMaC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery; Coronary Artery Bypass Graft; Surgical Aortic Valve Replacement

Keywords

autonomic nervous system; heart rate variability; cardiac surgery; major morbidities

Outcome Measures

Primary Outcomes (1)

• Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers

  Statistical model assessment; time series variability analysis

  24 months

Interventions

Acquisition of cardiovascular signals and microcirculation sidestream darkfield images DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 consecutive patients scheduled for major cardiac surgery

You may qualify if:

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

You may not qualify if:

• know autonomic nervous systems pathologies or dysfunctions
• pregnancy

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 31, 2023
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)