NCT05728047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

January 17, 2023

Last Update Submit

May 19, 2025

Conditions

Microvascular RarefactionHeart Valve DiseasesExtracorporeal Circulation

Keywords

microcirculationcapillary density

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled to heart valve surgery under cardiopulmonary bypass.

You may qualify if:

  • Patients scheduled to heart valve surgery under cardiopulmonary bypass.

You may not qualify if:

  • Patients operated on for infective endocarditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology

Rio de Janeiro, 21040-360, Brazil

Location

MeSH Terms

Conditions

Microvascular RarefactionHeart Valve Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 14, 2023

Study Start

September 10, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)