Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery

May 19, 2025 updated by: Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

Evaluation of Systemic Microcirculation During the Preoperative and Early Postoperative Periods of Patients Undergoing Heart Valve Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21040-360
        • National Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients scheduled to heart valve surgery under cardiopulmonary bypass.

Description

Inclusion Criteria:

  • Patients scheduled to heart valve surgery under cardiopulmonary bypass.

Exclusion Criteria:

  • Patients operated on for infective endocarditis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of systemic microcirculation
Time Frame: Change of microvascular density between the preoperative and up to four hours in the postoperative period.
Number of capillaries in the sublingual microcirculation.
Change of microvascular density between the preoperative and up to four hours in the postoperative period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2022

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 60999822.3.0000.5272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Valve Diseases

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe