Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery

Completed

• Conditions: Heart Valve Diseases; Extracorporeal Circulation; Microvascular Rarefaction

• Registration Number: NCT05728047
• Lead Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Brief 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.

Study Timeline

• Study Start: 2022-09-10
• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-14
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Patients scheduled to heart valve surgery under cardiopulmonary bypass.

Exclusion Criteria

• Patients operated on for infective endocarditis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of systemic microcirculation	Change of microvascular density between the preoperative and up to four hours in the postoperative period.	Number of capillaries in the sublingual microcirculation.

Trial Locations

Locations (1)

National Institute of Cardiology; 🇧🇷 Rio de Janeiro, Brazil