Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery

Surgery--Complications Clinical Trial

— MAPOVAS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04679077
• Other study ID #: MAPOVAS
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Surgery--Complications

Intervention

Other:
• Cytocam-IDF imaging device
Observation of the microcirculation

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative high-sensitive troponin T (hsTnT)	Indicator of acute coronary syndrome	30 days
Secondary	Cause of death	Causes of death	30 days
Secondary	Non-cardiovascular adverse events and serious adverse events	Incidence of non-cardiovascular complications	30 days
Secondary	Cardiovascular adverse events and serious adverse events	Incidence of cardiovascular complications	30 days
Secondary	Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period.	In addition, demographic parameters (age, weight, height) and comorbidities will be taken into account.	30