Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery

Sponsor
National Institute of Cardiology, Laranjeiras, Brazil (Other)
Overall Status
Recruiting
CT.gov ID
NCT05728047
Collaborator
(none)
31
1
5.7
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Evaluation of sublingual microcirculation with side-stream dark field imaging (cytocam)

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 Design

Study Type:
Observational
Anticipated Enrollment :
31 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Systemic Microcirculation During the Preoperative and Early Postoperative Periods of Patients Undergoing Heart Valve Surgery
Actual Study Start Date :
Sep 10, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients scheduled to heart valve surgery under cardiopulmonary bypass.
Exclusion Criteria:
  • Patients operated on for infective endocarditis

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of Cardiology Rio de Janeiro Brazil 21040-360

Sponsors and Collaborators

  • National Institute of Cardiology, Laranjeiras, Brazil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eduardo Tibirica, MD, PhD, Senior researcher, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier:
NCT05728047
Other Study ID Numbers:
  • CAAE 60999822.3.0000.5272
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eduardo Tibirica, MD, PhD, Senior researcher, National Institute of Cardiology, Laranjeiras, Brazil
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2023