Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery

NCT ID: NCT05728047

Last Updated: 2025-05-21

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

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-10

Study Completion Date

2024-09-01

Brief Summary

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The study aims to study the systemic microcirculation in adult patients hospitalized at a quaternary public hospital during the preoperative and immediate postoperative periods of heart valve surgery and correlations to their clinical and laboratory outcomes in the postoperative period.

Detailed Description

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Despite the development of new endovascular procedures in recent years, cardiac surgery currently remains an important instrument in the management of patients with severe heart diseases, such as hemodynamically significant coronary obstructions and valve pathologies.

Despite the advances in the management of patients in intensive care, the postoperative period of patients undergoing cardiac surgery remains a challenge due to the intense inflammatory reaction triggered by the surgical procedure itself and exacerbated by the use of cardiopulmonary bypass (CPB), fundamental in most cardiac surgeries performed nowadays.

In this context, cardiac surgery for the treatment of valve pathologies with the use of CPB is more related to unfavorable clinical outcomes in the postoperative period in relation to coronary artery bypass grafting (CABG). It is postulated, as a causal factor, the longer CPB time in valve surgeries associated with more prominent cardiac morphological changes in these patients.

Studies carried out in recent years in patients hospitalized in intensive care that developed a severe inflammatory reaction, either due to sepsis, surgical procedure or more recently due to the Covid-19 pandemic, have shown a frequent dissociation between the hemodynamic findings measured in the ICU with the data of the patients' systemic microcirculation.

The use of portable microscopes has allowed the measurement of systemic microcirculation at the bedside in intensive care, enabling prompt assessment of aspects related to tissue perfusion, thus seeking to improve clinical outcomes in these patients.

Conditions

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Microvascular Rarefaction Heart Valve Diseases Extracorporeal Circulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Evaluation of sublingual microcirculation with side-stream dark field imaging (cytocam)

The 'Cytocam' is a hand held computer-controlled device, a third generation video-microscope, which enables real time visualisation of the in vivo microcirculation, based upon the principle of incident dark field (IDF) illumination.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to heart valve surgery under cardiopulmonary bypass.

Exclusion Criteria

* Patients operated on for infective endocarditis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eduardo Tibirica, MD, PhD

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Institute of Cardiology

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAAE 60999822.3.0000.5272

Identifier Type: -

Identifier Source: org_study_id

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