Impact of Catheter Design on Catheter Survival in Chronic Hemodialysis Patients

Sponsor

AZ Sint-Jan AV (Other)

Overall Status

Completed

CT.gov ID

NCT01649102

Collaborator

(none)

302

Enrollment

Location

Arms

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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 Design

Study Type:

Interventional

Actual Enrollment :

302 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of Catheter Design on Catheter Survival in Chronic Hemodialysis Patients

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

overall catheter survival rate [3 years]

Secondary Outcome Measures

Mechanical catheter dysfunction: number of dialysis sessions requiring urokinase administration per 1000 catheter days; number of catheter removals for mechanical obstruction [3 years]

Other Outcome Measures

Dialysis efficiency: Kt/V; mean achieved blood flow rate per dialysis session [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.