Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-09-30

Brief Summary

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This study aims to compare two available types of central venous haemodialysis catheters (lines) - CVCs, and will examine how easy they are to insert, complications, blood flow on dialysis over time, line loss, line clotting and infective events. It will examine whether the LifeCath type of CVC can deliver high blood flow rates from first use after insertion and equivalent function and complication rate to the Tesio type of CVC that is in use in our centre already. Complications relating to dialysis access make up 30% of admissions for haemodialysis patients and so this is a study that could benefit patients and their care providers.

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Detailed Description

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Complications relating to dialysis access make up to 30% of admissions in haemodialysis patients. Comparative studies of complications between dialysis lines can help physicians and patients choose the best CVC type. In addition determining a type of dialysis line that can deliver good blood flows from the outset can minimise length of hospital stay for access creation. This study aims to perform a head-to-head comparison of two very similar (twin catheter) dialysis lines and examine short and long-term function as well as complication rates at our centre.

Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tesio Catheter

Patients randomised to receive the established catheter type in use at our centre \[control\]

Group Type ACTIVE_COMPARATOR

TesioCath

Intervention Type DEVICE

Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access

LifeCath

Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)

Group Type ACTIVE_COMPARATOR

LifeCath Twin

Intervention Type DEVICE

Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access

Interventions

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TesioCath

Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access

Intervention Type DEVICE

LifeCath Twin

Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access

Intervention Type DEVICE

Other Intervention Names

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BioFlex TesioCath (TM) - MedComp, Harleysville, PA, USA Vygon LifeCath Twin - Vygon(UK) Ltd, Cirencester, Gloucs, UK

Eligibility Criteria

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Inclusion Criteria

* Age \>=18 years old
* No history of prior central venous catheter insertion
* Medically fit for procedure (able to lie flat, no haemodynamic instability)
* No active infection (recent positive blood cultures, clinical signs of infection, CRP\>100)
* Able to give informed consent
* Expected to survive more than 12 months after catheter insertion