Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

Not Applicable

Completed

• Conditions: Hemodialysis
• Interventions: Device: TesioCath; Device: LifeCath Twin

• Registration Number: NCT01022359
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Primary Completion: 2010-07
• Study Completion: 2011-09
• Status Verified: 2021-03
• Results First Submitted: 2021-03-02
• Results First Submitted QC: 2021-03-26
• Last Update Submitted: 2021-03-26
• Results First Posted: 2021-04-22
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

• As above

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tesio Catheter	TesioCath	Patients randomised to receive the established catheter type in use at our centre \[control\]
LifeCath	LifeCath Twin	Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)

Primary Outcome Measures

Name	Time	Method
Blood Flow Rate at First Use After Insertion	First haemodialysis session after insertion

Secondary Outcome Measures

Name	Time	Method
Infective Episodes (Catheter & Non-catheter Related)	12 months
Achievement of Flow Rates>=450ml/Min at Dialysis Session	flow rate measured at each session; session at 12 months reported
Line Retention (Either/Both Lumens)	12 months
Catheter Dysfunction Requiring Use of Thrombolytic Agents	12 months
Complications at Catheter Insertion	Day 1
Recirculation Rates	12 months

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom