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Completed

NCT Number: NCT05728047

Evaluation of Systemic Microcirculation 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Cardiology

Rio de Janeiro, 21040-360, Brazil

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to heart valve surgery under cardiopulmonary bypass.

Exclusion criteria

  • Patients operated on for infective endocarditis

Treatment and study plan

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

Procedure

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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