Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery

Not Applicable

Withdrawn

• Conditions: Surgery--Complications
• Interventions: Other: Cytocam-IDF imaging device

• Registration Number: NCT04679077
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-22
• Study Start: 2021-02-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cytocam-IDF Imaging	Cytocam-IDF imaging device	All patients will undergo the same interventional test.

Primary Outcome Measures

Name	Time	Method
Postoperative high-sensitive troponin T (hsTnT)	30 days	Indicator of acute coronary syndrome

Secondary Outcome Measures

Name	Time	Method
Cardiovascular adverse events and serious adverse events	30 days	Incidence of cardiovascular complications
Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period.	30	In addition, demographic parameters (age, weight, height) and comorbidities will be taken into account.
Cause of death	30 days	Causes of death
Non-cardiovascular adverse events and serious adverse events	30 days	Incidence of non-cardiovascular complications

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussel, Belgium