Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters (VyTes)

Imperial College Healthcare NHS Trust

Status: Completed

Conditions: Hemodialysis

Treatments: Device: LifeCath Twin; Device: TesioCath

Study type: Interventional

Funder types: Other

Identifiers

NCT01022359

08/H0710/24

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• As above

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Tesio Catheter

Active Comparator group

Description:

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

Treatment:

Device: TesioCath

LifeCath

Active Comparator group

Description:

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

Treatment:

Device: LifeCath Twin