Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

Study Overview
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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.

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.

Official Title
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Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

Conditions
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Hemodialysis

Intervention / Treatment
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* Device: TesioCath
* Device: LifeCath Twin


Participation Criteria
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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 Exclusion Criteria: As above

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tesio Catheter<br>Patients randomised to receive the established catheter type in use at our centre [control] | Device: TesioCath<br>* Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access<br>* Other names: BioFlex TesioCath (TM) - MedComp, Harleysville, PA, USA;|
| Active Comparator: LifeCath<br>Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) | Device: LifeCath Twin<br>* Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access<br>* Other names: Vygon LifeCath Twin - Vygon(UK) Ltd, Cirencester, Gloucs, UK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Flow Rate at First Use After Insertion |  | First haemodialysis session after insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Infective Episodes (Catheter & Non-catheter Related) |  | 12 months | 
| Catheter Dysfunction Requiring Use of Thrombolytic Agents |  | 12 months | 
| Complications at Catheter Insertion |  | Day 1 | 
| Recirculation Rates |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haemodialysis, vascular access, central venous catheter