Clinical trial NCT05704140: Vienna Vascular Access Studied on Exchange of Dialysis Catheters for Shunts Where Feasible
Official title: Vienna Vascular Access Studied on Exchange of Dialysis Catheters for Shunts Where Feasible
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Failure on Dialysis
Keywords: Haemodialysis
Dialysis
Lead sponsor: Wilhelminenspital Vienna
Sponsor class: OTHER
Collaborators: name: Austrian Society of Vascular Surgery
First posted: 2023-01-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving catheter based dialysis in Vienna at the specified timepoint

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Age lower than 18

Primary outcomes:
measure: Arteriovenous VA
timeFrame: December 2022-May 2023
Secondary outcomes:
measure: Reasons for catheter based dialysis
timeFrame: December 2022-May 2023
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Klinik Ottakring
Study officials:
affiliation: Klinik Ottakring, Head of Departement of Vascular Surgery
name: Markus Plimon, MD
role: PRINCIPAL_INVESTIGATOR
References: