Catheter Related Bloodstream Infection Clinical Trial
Official title:
Impact of Catheter Design on Catheter Survival in Chronic Hemodialysis Patients
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00555282 -
Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of Two Different Central Venous Catheters (CVC)
|
Phase 4 | |
| Completed |
NCT00550693 -
Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
|
Phase 4 |