ClinicalTrials.gg
WithdrawnNCT04679077MAPOVASUpdated May 12, 2023

Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery

An interventional study of Cytocam-IDF imaging device in Surgery--Complications, sponsored by Universitair Ziekenhuis Brussel. Withdrawn at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Other

Why this study was withdrawn
Study was never submitted to the ethics committee
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery--Complications
03

In context

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 374 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Cytocam-IDF Imaging

    All patients will undergo the same interventional test.

    Other: Cytocam-IDF imaging device

Interventions

  • OtherCytocam-IDF imaging device

    Observation of the microcirculation

06

What researchers measure

Primary outcomes

  1. Postoperative high-sensitive troponin T (hsTnT)

    Indicator of acute coronary syndrome

    Time frame: 30 days

Secondary outcomes

  1. Cause of death

    Causes of death

    Time frame: 30 days

  2. Non-cardiovascular adverse events and serious adverse events

    Incidence of non-cardiovascular complications

    Time frame: 30 days

  3. Cardiovascular adverse events and serious adverse events

    Incidence of cardiovascular complications

    Time frame: 30 days

  4. 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.

    Time frame: 30

07

Study locations

1 site
  • UZ Brussel
    Jette, Brussels Capital 1090, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided — Presentations of both the study protocol and the study results will be held at conferences. After completion of the study and analysis of the data results will be made publicly without re striction, independent of the outcome. They will be submitted for publication to an international peer-reviewed journal.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2021; primary completion for Dec 2021, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2020
First posted
Dec 22, 2020
StartEst.
Feb 1, 2021
Primary completionEst.
Dec 31, 2021
CompletionEst.
Feb 1, 2022
Last update
May 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04679077
Responsible party
Sponsor
First posted
Dec 22, 2020
Start date
Feb 1, 2021 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Feb 1, 2022 (estimated)
Last update
May 12, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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