Vienna Vascular Access Studied on Exchange of Dialysis Ca... | NCT05704140

Studies
Vienna Vascular Access Studied on Exchange of Dialysis Catheters for Shunts Where Feasible

NCT05704140

Sponsor

Wilhelminenspital Vienna

Status

Unknown status

Last Update Posted

Jan 30, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

End Stage Renal Failure on Dialysis

Interventions

Catheter based Dialysis

Countries

Austria

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

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2022Actual

Primary Completion Date

May 1, 2023Estimated

Completion Date

Jun 1, 2023Estimated

First Submitted Date

Jan 19, 2023

First Submission Date that Met QC Criteria

Jan 19, 2023

First Posted Date

Jan 30, 2023Actual

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

Jan 19, 2023

Last Update Posted Date

Jan 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Markus Plimon, MD, Head of the vascular access unit, Wilhelminenspital ViennaPrincipal Investigator

Lead Sponsor

Wilhelminenspital ViennaOTHER

Collaborators

Name	Class
Austrian Society of Vascular Surgery	UNKNOWN

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

We will conduct a cross-section analysis regarding patients with catheter-based vascular Access (VA) in Vienna.

Collected data will include demographic and clinical information such as age, gender, co-morbidities and imaging data from sonography and computer tomography.

Patients of interest will be assessed through a standardized clinician-executed questionnaire aimed at investigating their medical history regarding their VA.

Patients will be evaluated for the feasibility of an arteriovenous VA. Patients will receive standard of care ultrasound-based arterial and venous mapping.

Detailed Description

We will conduct a cross-section analysis regarding patients with catheter-based vascular Access (VA) in Vienna.

Collected data will include demographic and clinical information such as age, gender, co-morbidities and imaging data from sonography and computer tomography.

Patients of interest will be assessed through a standardized clinician-executed questionnaire aimed at investigating their medical history regarding their VA.

Patients will be evaluated for the feasibility of an arteriovenous VA. Patients will receive standard of care ultrasound-based arterial and venous mapping.

Study Rationale The rate of dialysis via catheter systems is around 40% in Vienna whereas in neighboring Germany this rate is historically below 15% according to the latest update of the Dialysis Outcomes and Practice Patterns Study. Therefore, possibly up to 20% of the patients receiving chronic dialysis in Vienna could be eligible for an arteriovenous VA. In absolute numbers we expect up to 400 patients.

By means of Vienna ACTS NOW the current situation will be meticulously assessed with the aim to improve the provision of medical care for dialysis patients in Vienna by exchanging catheters for arteriovenous VAs (where feasible and desired).

The collected data will serve as the basis of a future prospective interventional study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
catheter based dialysis		All patients receiving catheter based dialysis in Vienna as of November 2022	Other: Catheter based Dialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Catheter based Dialysis	Other	We will conduct a cross-section analysis regarding patients with catheter-based VA in Vienna.	catheter based dialysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Arteriovenous VA	After a standard-of-care vascular mapping we will note the number of patients receiving catheter based dialysis who would be eligible for arteriovenous dialysis access.	December 2022-May 2023

Secondary Outcomes

Measure	Description	Time Frame
Reasons for catheter based dialysis	We use a standardized questionnaire to assess the vascular access (VA) history of patients and why they are receiving catheter based dialysis.	December 2022-May 2023

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 18 and above
Catheter-based dialysis as of 01.11.2022

Exclusion Criteria:

• Age lower than 18

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

All patients receiving catheter based dialysis in Vienna at the specified timepoint

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Markus Plimon, MD	Contact	+43 1 49150	4106	kor.1ch@gesundheitsverbund.at

Overall Officials

Name	Affiliation	Role
Markus Plimon, MD	Klinik Ottakring, Head of Departement of Vascular Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik Ottakring	Recruiting	Vienna		1160	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided