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Clinical Trials/NCT04679077
NCT04679077WithdrawnNot Applicable

Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery: a Prospective Cohort Study

Universitair Ziekenhuis Brussel1 site in 1 countryStarted: February 1, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Postoperative high-sensitive troponin T (hsTnT)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of the study is to determine whether there is a correlation between the microcirculation measured preoperatively in patients undergoing major vascular surgery and the postoperative mortality during hospitalization period. The microcirculation will be measured sublingually with the Cytocam-IDF imaging technique.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age ≥ 18 years
  • •Males and females
  • •ASA III classification
  • •Written informed consent obtained by the patient
  • •Elective hospital admission for major vascular surgery, both open and endovascular

Exclusion Criteria

  • •Emergency surgery
  • •Minor vascular procedures (e.g. varicose vein stripping; thromboembolectomy; vascular access formation)
  • •Pregnancy
  • •Refusal or inability to provide written informed consent (language barrier, mental retardation)

Arms & Interventions

Cytocam-IDF Imaging

Other

All patients will undergo the same interventional test.

Intervention: Cytocam-IDF imaging device (Other)

Outcomes

Primary Outcomes

Postoperative high-sensitive troponin T (hsTnT)

Time Frame: 30 days

Indicator of acute coronary syndrome

Secondary Outcomes

  • Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period.(30)
  • Cardiovascular adverse events and serious adverse events(30 days)
  • Cause of death(30 days)
  • Non-cardiovascular adverse events and serious adverse events(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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