End Stage Renal Disease on Dialysis (Diagnosis)NCT03523260
Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)
A study testing Tunneled dialysis catheter placement. in people with End Stage Renal Disease on Dialysis (Diagnosis), run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis (Diagnosis)
- What is being tested?
- Tunneled dialysis catheter placement.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2013to 22 Jan 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide a written informed consent
- 19 years or older
- Hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein.
- Patent left internal jugular vein.
- Able to read and understand English.
Who cannot join
- Previous enrollment in this trial
- Patients unable or unwilling to provide informed consent
- Prisoners or incarcerated individuals
- Women who are pregnant
- Patients in whom the left internal jugular vein is occluded or catheter placement is otherwise contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Akabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: High-Flow Hemodialysis Catheters Placed Through the Left Internal Jugular Approach (R12-022)
The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. This study will review and compare the complication rate and function of the three catheter designs.
Read the detailed description
The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. Participants will be randomized to receive a split-tip, step-tip or symmetric tip catheter in a 1:1:1 ratio. All participants will be followed per their referring physician's standard of care. Information regarding any patient complications will be obtained from Dr. Allon's dialysis patient database (Vascular Access in Hemodialysis Patients, IRB # X980813005). This study will review and compare the complication rate and function of the three catheter designs. There are no studies to our knowledge that compared catheter designs placed specifically via the left internal jugular vein. The investigators hypothesize that because the left internal jugular vein is anatomically more complex than the right one, tunneled dialysis catheters with split-tip design may perform sub-optimally, compared to step-tip and symmetric tip designs, when placed via the left internal jugular vein. If this hypothesis is true, the results of the study may influence future clinical practice and reduce the rates of replacement of catheters placed through the left internal jugular vein, resulting in better patient care and significant cost-savings.
- Being tested
- Tunneled dialysis catheter placement.
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunneled dialysis catheter placement.Device
Placement of high-flow tunneled catheter for hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Tunneled dialysis Split-tip catheter | Active comparator | High-flow tunneled Split-tip catheter for hemodialysis will be inserted by standard interventional technique Receives: Device: Tunneled dialysis catheter placement. |
| Tunneled dialysis Step-tip catheter | Active comparator | High-flow tunneled Step-tip catheter for hemodialysis will be inserted by standard interventional technique Receives: Device: Tunneled dialysis catheter placement. |
| Tunneled dialysis Symmetric tip catheter | Active comparator | High-flow tunneled Symmetric tip catheter for hemodialysis will be inserted by standard interventional technique Receives: Device: Tunneled dialysis catheter placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
1 month complication rate of left internal jugular vein dialysis catheters
Measured: 1 month
Secondary outcomes (5)
Catheter dysfunction
1 month complication rate of left internal jugular vein dialysis catheters
Measured: 1 months
Catheter dysfunction
3 months complication rate of left internal jugular vein dialysis catheters
Measured: 3 months
Catheter dysfunction
6 months complication rate of left internal jugular vein dialysis catheters
Measured: 6 months
Complication rate
3 months complication rate of left internal jugular vein dialysis catheters
Measured: 3 months
Complication rate
6 months complication rate of left internal jugular vein dialysis catheters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start27 Aug 2013
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Why it stopped: Never funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on Dialysis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Husameddin M El Khudari, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523260
- Sponsor's protocol ID
- IRB-130430002
- Status last verified
- May 2021
- First submitted
- 7 Feb 2018
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Hemodialysis Catheters Placed Through the Left Internal Jugular Approach (R12-022)
- ClinicalTrials.gov ID
- NCT03523260
- Acronym / sponsor ID
- IRB-130430002
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 27 Aug 2013 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 14 May 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.
The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. This study will review and compare the complication rate and function of the three catheter designs.
Detailed description
The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. Participants will be randomized to receive a split-tip, step-tip or symmetric tip catheter in a 1:1:1 ratio. All participants will be followed per their referring physician's standard of care. Information regarding any patient complications will be obtained from Dr. Allon's dialysis patient database (Vascular Access in Hemodialysis Patients, IRB # X980813005). This study will review and compare the complication rate and function of the three catheter designs. There are no studies to our knowledge that compared catheter designs placed specifically via the left internal jugular vein. The investigators hypothesize that because the left internal jugular vein is anatomically more complex than the right one, tunneled dialysis catheters with split-tip design may perform sub-optimally, compared to step-tip and symmetric tip designs, when placed via the left internal jugular vein. If this hypothesis is true, the results of the study may influence future clinical practice and reduce the rates of replacement of catheters placed through the left internal jugular vein, resulting in better patient care and significant cost-savings.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tunneled dialysis Split-tip catheter | Active comparator | Device: Tunneled dialysis catheter placement.High-flow tunneled Split-tip catheter for hemodialysis will be inserted by standard interventional technique |
| Tunneled dialysis Step-tip catheter | Active comparator | Device: Tunneled dialysis catheter placement.High-flow tunneled Step-tip catheter for hemodialysis will be inserted by standard interventional technique |
| Tunneled dialysis Symmetric tip catheter | Active comparator | Device: Tunneled dialysis catheter placement.High-flow tunneled Symmetric tip catheter for hemodialysis will be inserted by standard interventional technique |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to provide a written informed consent
- 19 years or older
- Hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein.
- Patent left internal jugular vein.
- Able to read and understand English.
Key exclusion criteria (5 listed)
- Previous enrollment in this trial
- Patients unable or unwilling to provide informed consent
- Prisoners or incarcerated individuals
- Women who are pregnant
- Patients in whom the left internal jugular vein is occluded or catheter placement is otherwise contraindicated
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 |
|---|---|---|
| Tunneled dialysis catheter placement.Placement of high-flow tunneled catheter for hemodialysis | Device | Tunneled dialysis Split-tip catheter, Tunneled dialysis Step-tip catheter, Tunneled dialysis Symmetric tip catheter |
Primary outcome
Complication rate
Time frame: 1 month
1 month complication rate of left internal jugular vein dialysis catheters
5 secondary outcomes
Catheter dysfunction
Time frame: 1 months
Catheter dysfunction
Time frame: 3 months
Catheter dysfunction
Time frame: 6 months
Complication rate
Time frame: 3 months
Complication rate
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunneled dialysis catheter placement. in people with End Stage Renal Disease on Dialysis (Diagnosis), run by University of Alabama at Birmingham at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 10 May 2021. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: 1 month). 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 10 May 2021.