Preoperative Microcirculation and Postoperative Outcome A... | NCT04679077

Studies
Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery

NCT04679077

Sponsor

Universitair Ziekenhuis Brussel

Status

Withdrawn

Last Update Posted

May 12, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Surgery--Complications

Interventions

Cytocam-IDF imaging device

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was never submitted to the ethics committee

Expanded Access Info

Start Date

Feb 1, 2021Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Feb 1, 2022Estimated

First Submitted Date

Dec 9, 2020

First Submission Date that Met QC Criteria

Dec 17, 2020

First Posted Date

Dec 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2023

Last Update Posted Date

May 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cytocam-IDF Imaging	Other	All patients will undergo the same interventional test.	Other: Cytocam-IDF imaging device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytocam-IDF imaging device	Other	Observation of the microcirculation	Cytocam-IDF Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative high-sensitive troponin T (hsTnT)	Indicator of acute coronary syndrome	30 days

Secondary Outcomes

Measure	Description	Time Frame
Cause of death	Causes of death	30 days
Non-cardiovascular adverse events and serious adverse events	Incidence of non-cardiovascular complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Brussel		Jette	Brussels Capital	1090	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided