Clinical Trials Directory

Trials / Completed

CompletedNCT05728047

Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery

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

Status
Completed
Phase
Study type
Observational
Enrollment
31 (actual)
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil · Other Government
Sex
All
Age
18 Years – 75 Years
Healthy volunteers

Summary

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

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

Interventions

TypeNameDescription
PROCEDUREEvaluation 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.

Timeline

Start date
2022-09-10
Primary completion
2024-09-01
Completion
2024-09-01
First posted
2023-02-14
Last updated
2025-05-21

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT05728047. Inclusion in this directory is not an endorsement.