End Stage Renal DiseaseAUSTRIANCT03764358
AUSTrian Randomized Interventional Study on Dialysis Accesses
A study testing Arteriovenous Fistula and Tunneled Cuffed Catheter in people with End Stage Renal Disease and Catheter Infection, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- End Stage Renal Disease, Catheter Infection, Shunt Malfunction
- What is being tested?
- Arteriovenous Fistula and Tunneled Cuffed Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteAustria
- Study dates
- 6 Mar 2019to 4 Oct 2022
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 60 and higher
- CCI Score >6 when under 60 years
- Patients with CKD G5 A1-3 with indication for hemodialysis
- Stable clinical condition
- Eligibility for both arteriovenous fistula on the upper extremitiesandTCC
- Availability for follow-up.
- Written informed consent.
Who cannot join
- Uncontrolled infection at screening and/or CRP >5 mg/dl (normal <0.5 mg/dl) at screening.
- Poor general condition of health or malignancy not in remission at screening
- Major surgery within 12 weeks before screening.
- Pre-existent vascular access.
- Patient not eligible for any one of the vascular access options.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna
Vienna, 1090
Benjamin Schairer, MD, 0043 40400 ext. 43890, benjamin.schairer@meduniwien.ac.at
About this study
Official title: Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index >6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.
- Being tested
- Arteriovenous Fistula, Tunneled Cuffed Catheter
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriovenous FistulaDevice
Surgical implantation of an arteriovenous fistula for hemodialysis
Tunneled Cuffed CatheterDevice
Placement of a tunneled cuffed catheter in surgical theatre
| Study group | Role | What they receive |
|---|---|---|
| Arteriovenous fistula | Active comparator | Not described Receives: Device: Arteriovenous Fistula |
| Tunneled Cuffed Catheter | Experimental | Not described Receives: Device: Tunneled Cuffed Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary end-point of any access related complication
Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis
Measured: From placement of vascular access through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start6 Mar 2019 (estimated)
- Primary completion4 Apr 2022 (estimated)
- Study completion4 Oct 2022 (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 DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guerkan SENGOELGE, Medical University of Vienna
- Investigators
- Guerkan Sengoelge, MD, Principal investigator, Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764358
- Sponsor's protocol ID
- AUSTRIA
- Acronym
- AUSTRIA
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
- ClinicalTrials.gov ID
- NCT03764358
- Acronym / sponsor ID
- AUSTRIA / AUSTRIA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 6 Mar 2019 (estimated)
- Primary completion
- 4 Apr 2022 (estimated)
- Study completion
- 4 Oct 2022 (estimated)
- First posted
- 5 Dec 2018 (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.
Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index >6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arteriovenous fistula | Active comparator | Device: Arteriovenous Fistula |
| Tunneled Cuffed Catheter | Experimental | Device: Tunneled Cuffed Catheter |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of 60 and higher
- CCI Score >6 when under 60 years
- Patients with CKD G5 A1-3 with indication for hemodialysis
- Stable clinical condition
- Eligibility for both arteriovenous fistula on the upper extremitiesandTCC
Key exclusion criteria (5 listed)
- Uncontrolled infection at screening and/or CRP >5 mg/dl (normal <0.5 mg/dl) at screening.
- Poor general condition of health or malignancy not in remission at screening
- Major surgery within 12 weeks before screening.
- Pre-existent vascular access.
- Patient not eligible for any one of the vascular access options.
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 |
|---|---|---|
| Arteriovenous FistulaSurgical implantation of an arteriovenous fistula for hemodialysis | Device | Arteriovenous fistula |
| Tunneled Cuffed CatheterPlacement of a tunneled cuffed catheter in surgical theatre | Device | Tunneled Cuffed Catheter |
Primary outcome
Composite primary end-point of any access related complication
Time frame: From placement of vascular access through study completion, an average of 3 years.
Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Guerkan Sengoelge, MD principal investigator
Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arteriovenous Fistula and Tunneled Cuffed Catheter in people with End Stage Renal Disease and Catheter Infection, run by Medical University of 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 7 inclusion and 5 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 5 Dec 2018. 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 Benjamin Schairer, MD (0043 40400 43890, benjamin.schairer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary end-point of any access related complication (time frame: From placement of vascular access through study completion, an average of 3 years.). 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 5 Dec 2018; AzTrials last refreshed its copy on 28 Oct 2026.