End Stage Renal Failure on DialysisViennaACTSNOWNCT05704140
Vienna Vascular Access Studied on Exchange of Dialysis Catheters for Shunts Where Feasible
An observational study of End Stage Renal Failure on Dialysis, run by Wilhelminenspital Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- Catheter based Dialysis
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- 15 Dec 2022to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients receiving catheter based dialysis in Vienna at the specified timepoint
Who may be able to join
- Age of 18 and above
- Catheter-based dialysis as of 01.11.2022
Who cannot join
- Age lower than 18
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Klinik Ottakring
Vienna, 1160
Markus Plimon, MD, +43 1 49150 ext. 4106, kor.1ch@gesundheitsverbund.at
About this study
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.
Read the 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.
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- Catheter based Dialysis
- Keywords
- Haemodialysis, Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter based DialysisOther
We will conduct a cross-section analysis regarding patients with catheter-based VA in Vienna.
| Study group | Role | What they receive |
|---|---|---|
| catheter based dialysis | All patients receiving catheter based dialysis in Vienna as of November 2022 Receives: Other: Catheter based Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December 2022-May 2023
Secondary outcomes (1)
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.
Measured: December 2022-May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start15 Dec 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wilhelminenspital Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Society of Vascular Surgery
- Responsible party
- Principal investigator, Markus Plimon, MD, Wilhelminenspital Vienna
- Investigators
- Markus Plimon, MD, Principal investigator, Klinik Ottakring, Head of Departement of Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704140
- Sponsor's protocol ID
- 22-104-VK
- Acronym
- ViennaACTSNOW
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vienna Vascular Access Studied on Exchange of Dialysis Catheters for Shunts Where Feasible
- ClinicalTrials.gov ID
- NCT05704140
- Acronym / sponsor ID
- ViennaACTSNOW / 22-104-VK
- Conditions
- End Stage Renal Failure on Dialysis
- Keywords
- Haemodialysis, Dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wilhelminenspital ViennaUniversity, hospital or other
- Collaborators
- Austrian Society of Vascular Surgery
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| catheter based dialysis | – | Other: Catheter based DialysisAll patients receiving catheter based dialysis in Vienna as of November 2022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving catheter based dialysis in Vienna at the specified timepoint
Key inclusion criteria (2 listed)
- Age of 18 and above
- Catheter-based dialysis as of 01.11.2022
Key exclusion criteria (1 listed)
- Age lower than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter based DialysisWe will conduct a cross-section analysis regarding patients with catheter-based VA in Vienna. | Other | catheter based dialysis |
Primary outcome
Arteriovenous VA
Time frame: 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.
1 secondary outcome
Reasons for catheter based dialysis
Time frame: December 2022-May 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Failure on Dialysis
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Plimon, MD principal investigator
Klinik Ottakring, Head of Departement of Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Failure on Dialysis, run by Wilhelminenspital Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Plimon, MD (+43 1 49150 ext. 4106, kor.1ch@gesundheitsverbund.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arteriovenous VA (time frame: December 2022-May 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.