Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery

NCT04679077 | Withdrawn

• 1 other identifier: MAPOVAS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery--Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative high-sensitive troponin T (hsTnT)

  Indicator of acute coronary syndrome

  30 days

Secondary Outcomes (4)

• Cause of death

  30 days

• Non-cardiovascular adverse events and serious adverse events

  30 days

• Cardiovascular adverse events and serious adverse events

  30 days

• Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period.

  30

Study Arms (1)

Cytocam-IDF Imaging

OTHER

All patients will undergo the same interventional test.

Other: Cytocam-IDF imaging device

Interventions

Cytocam-IDF imaging device OTHER

Observation of the microcirculation

Cytocam-IDF Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be split into two groups after data collection. They will receive the same treatment during the clinical trial.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 22, 2020
• Study Start: February 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 1, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

BE (1)