End Stage Renal DiseaseNCT00526123

Dialysis Catheter Comparative Clinical Trial

A study testing Symmetric Tip Catheter and Conventional Split-tip Catheter in people with End Stage Renal Disease, run by Tyco Healthcare Group at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical trial is to compare the longevity of two dialysis catheters. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: Symmetric Tip Catheter and Conventional Split-tip Catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 599 participants
Where: 14 sitesUnited States
Study dates: Sep 2007to Aug 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Subject must be 18 years of age or older.
Subject must meet labeled indication for hemodialysis.
Subject must have End Stage Renal Disease (ESRD).
Subject must have a patent right or left internal jugular vein.
Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks.
Subject must give written informed consent.

Who cannot join

Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study.
Subjects with active infection at the time of study enrollment.
Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period.
Subjects for whom performing dialysis at flow rates up to 450 mL/min would be contraindicated for any reason.
Subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study.
Subjects who, in the opinion of the Investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Nephrology Associates, P.C.
Birmingham, Alabama, 35211
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Columbia Nephrology Associates
Columbia, South Carolina, 29203
Eastern Nephrology Associates
Greenville, North Carolina, 27834
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Eastern Nephrology Associates
New Bern, North Carolina, 28562
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Southwest Kidney Institute
Phoenix, Arizona, 85004
Boice-Willis Clinic
Rocky Mount, North Carolina, 27804
SUNY Stony Brook Medical Center
Stony Brook, New York, 11794
Toledo Hospital
Toledo, Ohio, 43606
Dialysis Access Group of Wake Forest University, LLC
Winston-Salem, North Carolina, 27101
Nephrology Associates - Lankenau Hospital
Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: A Randomized, Open-label Comparison of the Performance and Longevity of a Split-tip Versus a Symmetric Tip Hemodialysis

The purpose of this clinical trial is to compare the longevity of two dialysis catheters.

Read the detailed description

This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.

Conditions: End Stage Renal Disease
Being tested: Symmetric Tip Catheter, Conventional Split-tip Catheter
Keywords: Dialysis, Dialysis Catheter, Kidney Disease, Dialysis Clinic, Chronic Catheter, Catheter, Kidney
Medical subject headings: Kidney Failure, Chronic, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Symmetric Tip CatheterDevice
Dialysis catheter
Conventional Split-tip CatheterDevice
Dialysis Catheter

Study groups in NCT00526123
Study group	Role	What they receive
1	Active comparator	symmetric tip catheter Receives: Device: Symmetric Tip Catheter
2	Active comparator	conventional split-tip catheter Receives: Device: Conventional Split-tip Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Measured: 30 days
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Measured: 60 days
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Measured: 245 days

Secondary outcomes (5)

Inadequate Flow Rates Requiring Surgical/Radiological Intervention
Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.
Measured: 35 weeks
Average Number of Line Reversals Per Subject
Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments
Measured: 35 Weeks
Frequency of Clinician Interventions for Catheter Malfunction and Infection
Average number of times clinician intervention was required for either catheter malfunction or infection
Measured: 35 Weeks
Primary Failure Rate
The percentage of catheters unable to deliver adequate blood flow of at least 300 mL/min for at least 50% of measurements during the first attempted dialysis session.
Measured: First dialysis session with study catheter
Reliability of the Catheter
Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.
Measured: 35 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Aug 2011

First posted6 Sep 2007 (estimated)
Study startSep 2007
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for End Stage Renal DiseaseStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 599 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00526123
Sponsor's protocol ID: 341.26
Status last verified: Jan 2013
First submitted: 5 Sep 2007
Last updated: 7 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Comparison of the Performance and Longevity of a Split-tip Versus a Symmetric Tip Hemodialysis
ClinicalTrials.gov ID: NCT00526123
Acronym / sponsor ID: 341.26
Conditions: End Stage Renal Disease
Keywords: Dialysis, Dialysis Catheter, Kidney Disease, Dialysis Clinic, Chronic Catheter, Catheter, Kidney
Study type: Interventional
Recruitment status: Completed
Enrolment: 599 participants (actual)
Lead sponsor: Tyco Healthcare GroupIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 6 Sep 2007 (estimated)
Results: Posted 7 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this clinical trial is to compare the longevity of two dialysis catheters.

Detailed description

This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Device: Symmetric Tip Cathetersymmetric tip catheter
2	Active comparator	Device: Conventional Split-tip Catheterconventional split-tip catheter

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject must be 18 years of age or older.
Subject must meet labeled indication for hemodialysis.
Subject must have End Stage Renal Disease (ESRD).
Subject must have a patent right or left internal jugular vein.
Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks.

Key exclusion criteria (8 listed)

Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study.
Subjects with active infection at the time of study enrollment.
Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period.

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
Symmetric Tip CatheterDialysis catheter	Device	1
Conventional Split-tip CatheterDialysis Catheter	Device	2

Primary outcome

First Catheter Induced Complication
Time frame: 30 days
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
First Catheter Induced Complication
Time frame: 60 days
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
First Catheter Induced Complication
Time frame: 245 days
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

5 secondary outcomes

Inadequate Flow Rates Requiring Surgical/Radiological Intervention
Time frame: 35 weeks
Average Number of Line Reversals Per Subject
Time frame: 35 Weeks
Frequency of Clinician Interventions for Catheter Malfunction and Infection
Time frame: 35 Weeks
Primary Failure Rate
Time frame: First dialysis session with study catheter
Reliability of the Catheter
Time frame: 35 Weeks

Results and safety

Results posted to the registry on 7 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symmetric Tip	303	39
Split-tip	296	50

Primary outcome: First Catheter Induced Complication

Time frame: 30 days. Number. Unit: percentage of participants

Measure	Symmetric Tip n = 285	Split-tip n = 283
Value	78	77

Population analysed: Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.

Primary outcome: First Catheter Induced Complication

Time frame: 60 days. Number. Unit: percentage of participants

Measure	Symmetric Tip n = 285	Split-tip n = 283
Value	66	69

Primary outcome: First Catheter Induced Complication

Time frame: 245 days. Number. Unit: percentage of participants

Measure	Symmetric Tip n = 285	Split-tip n = 283
Value	40	48

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symmetric Tip	11 of 303 (3.6%)	0 of 303 (0%)	Not reported
Split-tip	4 of 296 (1.4%)	0 of 296 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Klemens B Meyer, MD principal investigator

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Symmetric Tip Catheter and Conventional Split-tip Catheter in people with End Stage Renal Disease, run by Tyco Healthcare Group at 14 sites 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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?

Yes. Results are posted in the registry (first posted 7 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

First Catheter Induced Complication (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00526123.

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 7 Jan 2013; AzTrials last refreshed its copy on 30 Oct 2026.