Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728047
• Other study ID #: CAAE 60999822.3.0000.5272
• Status: Recruiting
• Start date: September 10, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: Eduardo Tibirica, MD, PhD
• Phone: +55-21-99914-6075
• Email: etibi[@]uol.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients scheduled to heart valve surgery under cardiopulmonary bypass.

Exclusion Criteria:

• Patients operated on for infective endocarditis

Related Conditions & MeSH terms

• Extracorporeal Circulation
• Heart Valve Diseases
• Microvascular Rarefaction

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Brazil	National Institute of Cardiology	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of systemic microcirculation	Number of capillaries in the sublingual microcirculation.	Change of microvascular density between the preoperative and up to four hours in the postoperative period.