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

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 Overview

• Status: Recruiting
• Conditions: End Stage Renal Failure on Dialysis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Markus Plimon, MD; Phone Number: 4106 +43 1 49150; Email: kor.1ch@gesundheitsverbund.at

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Recruiting
    • Klinik Ottakring
    • Contact: Markus Plimon, MD; Phone Number: 4106 +43 1 49150; Email: kor.1ch@gesundheitsverbund.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age lower than 18

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wilhelminenspital Vienna
• Collaborators: Austrian Society of Vascular Surgery
• Investigators: Principal Investigator: Markus Plimon, MD, Klinik Ottakring, Head of Departement of Vascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Dialysis; Haemodialysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 22-104-VK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No