Impact of Catheter Design on Catheter Survival in Chronic Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by AZ Sint-Jan AV.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. An De Vriese, AZ Sint-Jan AV
ClinicalTrials.gov Identifier:
NCT01649102
First received: July 18, 2012
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

The trial aims to compare the performance of two tunneled cuffed catheters (TCC) in chronic hemodialysis patients. The design of the catheter may affect the propensity for thrombosis and hence intraluminal infection, as well the percentage of recirculation and hence the efficiency of dialysis.


Condition Intervention Phase
Chronic Hemodialysis
Catheter Related Bloodstream Infection
Mechanical Catheter Dysfunction
Device: Tunneled Cuffed Catheter (Palindroom, Hemoglide Bard)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Catheter Design on Catheter Survival in Chronic Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by AZ Sint-Jan AV:

Primary Outcome Measures:
  • overall catheter survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Dialysis efficiency: Kt/V; mean achieved blood flow rate per dialysis session [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palindroom catheter
Insertion of Palindroom catheter
Device: Tunneled Cuffed Catheter (Palindroom, Hemoglide Bard)

A tunneled cuffed catheter is inserted, randomization between:

  • Palindroom
  • Hemoglide Bard
Experimental: Hemoglide Bard Catheter
Insertion of Hemoglide Bard Catheter
Device: Tunneled Cuffed Catheter (Palindroom, Hemoglide Bard)

A tunneled cuffed catheter is inserted, randomization between:

  • Palindroom
  • Hemoglide Bard

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649102

Contacts
Contact: An S De Vriese, M.D., Ph.D. +32 50452200 an.devriese@azsintjan.be
Contact: Stefaan Vandecasteele, M.D., Ph.D. +32 50452200 stefaan.vandecasteele@azsintjan.be

Locations
Belgium
AZ ST JAn Brugge Oostende AV Recruiting
Brugge, Belgium, B-8000
Contact: An S De Vriese, M.D., Ph.D.       an.devriese@azsintjan.be   
Principal Investigator: An S De Vriese, M.D., Ph.D.         
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
Principal Investigator: An S De Vriese, M.D., Ph.D. AZ ST JAN Brugge Oostende AV
  More Information

No publications provided

Responsible Party: Prof. Dr. An De Vriese, M.D., Ph. D., AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT01649102     History of Changes
Other Study ID Numbers: B04920108373
Study First Received: July 18, 2012
Last Updated: July 24, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by AZ Sint-Jan AV:
Chronic hemodialysis
Tunneled cuffed catheter
Catheter-related bloodstream infection
Mechanical catheter dysfunction
impact of catheter design on outcome

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on September 22, 2014