- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01649102
Impact of Catheter Design on Catheter Survival in Chronic Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The use of tunneled cuffed catheters (TCCs) as vascular access is discouraged in the NKF DOQI guidelines, because of their propensity for infection, thrombosis, inadequate and/or irregular blood flow rates and damage to large central veins. In addition, emerging data suggest a link between catheter use and cardiovascular morbidity and mortality. Nevertheless, they are still frequently used in the hemodialysis population, either because of documented inadequate vascular access anatomy, or as a bridge to a functional permanent access.
A large number of TCC are available, that mainly differ with respect to material type, lumen diameter and design, tip design, as well as presence and design of side holes. There is currently no proven advantage of one long-term catheter design over another.
The design of the catheter tip may affect the propensity for thrombosis and hence intraluminal infection, as well the percentage of recirculation, especially when arterial and venous blood tubing are reversed. Commonly used catheters have a staggered tip design, meaning that the outflow tip extends several centimetres (typically a minimum of 2.5 cm) beyond the inflow tip, to prevent recirculation. Other designs are a split tip, or a symmetrical tip. In the latter type, used in the Palindrome® (Covidien) catheter, a spiral separator is incorporated allowing either lumen to be used as the arterial port.
Many catheters have multiple side holes, to decrease shear rate and increase flow on the arterial side and reflecting the belief that backup inflow is necessary in the case of obstruction. However, side holes can also promote thrombosis and infection due to the irregularity of their cut surfaces. Especially the distal side holes comprise a low flow zone with an increased clotting risk. The Palindrome® (Covidien) catheter has laser cut side holes, which are thought to have a smoother surface and a lower tendency to cause thrombosis.
Inadequate blood flow in a catheter is often mended by reversal of the inlet and outlet lumens. However, reversal of flow leads to a substantial increase of recirculation (from 2%-3% to 10%), affecting the efficiency of treatment. It should therefore never be used except temporarily until the problem is definitively corrected. The symmetrical tip design of the Palindrome® (Covidien) catheter allows lumen reversal without increased recirculation.
The present randomized controlled trial (RCT) is designed to evaluate in chronic hemodialysis patients the performance of two TCC with different design: the Palindrome® (Covidien), which is a symmetrical spiral z-tip catheter made from carbothane and the Hemoglide® (Bard), which has a 3 cm staggered tip and is made of polyurethane.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Brugge, Belgium, B-8000
- AZ ST JAn Brugge Oostende AV
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All patients (male or female, age < 18 years) on chronic hemodialysis who require a tunneled cuffed catheter as temporary or definite vascular access are eligible. Written informed consent is required prior to inclusion.
Exclusion Criteria:
- Pregnancy or breast-feeding
- Life-expectance of < 6 months due to major co-morbid conditions
- Inability to provide informed consent
- Occlusion or inaccessibility of the right internal jugular vein
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Palindroom catheter
Insertion of Palindroom catheter
|
A tunneled cuffed catheter is inserted, randomization between:
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Experimental: Hemoglide Bard Catheter
Insertion of Hemoglide Bard Catheter
|
A tunneled cuffed catheter is inserted, randomization between:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall catheter survival rate
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mechanical catheter dysfunction: number of dialysis sessions requiring urokinase administration per 1000 catheter days; number of catheter removals for mechanical obstruction
Time Frame: 3 years
|
3 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dialysis efficiency: Kt/V; mean achieved blood flow rate per dialysis session
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: An S De Vriese, M.D., Ph.D., AZ ST JAn Brugge Oostende AV
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B04920108373
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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