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

End Stage Renal Failure on Dialysis Clinical Trial

— ViennaACTSNOW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704140
• Other study ID #: 22-104-VK
• Status: Recruiting
• Start date: December 15, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2023
• Source: Wilhelminenspital Vienna
• Contact: Markus Plimon, MD
• Phone: +43 1 49150
• Email: kor.1ch[@]gesundheitsverbund.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of 18 and above

• Catheter-based dialysis as of 01.11.2022

Exclusion Criteria:

• Age lower than 18

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

Intervention

Other:
• Catheter based Dialysis
We will conduct a cross-section analysis regarding patients with catheter-based VA in Vienna.

Locations

Country	Name	City	State
Austria	Klinik Ottakring	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Wilhelminenspital Vienna	Austrian Society of Vascular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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