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

Sponsor

Wilhelminenspital Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT05704140

Collaborator

Austrian Society of Vascular Surgery (Other)

400

Enrollment

Location

5.5

Anticipated Duration (Months)

72.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Failure on Dialysis	Other: Catheter based Dialysis

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
catheter based dialysis All patients receiving catheter based dialysis in Vienna as of November 2022	Other: Catheter based Dialysis We will conduct a cross-section analysis regarding patients with catheter-based VA in Vienna.

Arm

Intervention/Treatment

catheter based dialysis

All patients receiving catheter based dialysis in Vienna as of November 2022

Other: Catheter based Dialysis

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

Outcome Measures

Primary Outcome Measures

Arteriovenous VA [December 2022-May 2023]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

• Age lower than 18

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik Ottakring	Vienna		Austria	1160

Sponsors and Collaborators

Wilhelminenspital Vienna
Austrian Society of Vascular Surgery

Investigators

Principal Investigator: Markus Plimon, MD, Klinik Ottakring, Head of Departement of Vascular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Markus Plimon, MD, Head of the vascular access unit, Wilhelminenspital Vienna

ClinicalTrials.gov Identifier:

NCT05704140

Other Study ID Numbers:

22-104-VK

First Posted:

Jan 30, 2023

Last Update Posted:

Jan 30, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Markus Plimon, MD, Head of the vascular access unit, Wilhelminenspital Vienna

Haemodialysis

Dialysis

Additional relevant MeSH terms:

Kidney Failure, Chronic

Study Results

No Results Posted as of Jan 30, 2023