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OpenTrials
Completed

NCT Number: NCT01022359

Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

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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Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TesioCath

Device

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

Other names: BioFlex TesioCath (TM) - MedComp, Harleysville, PA, USA

LifeCath Twin

Device

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

Other names: Vygon LifeCath Twin - Vygon(UK) Ltd, Cirencester, Gloucs, UK

Primary outcomes

  1. Blood Flow Rate at First Use After Insertion

    Time frame: First haemodialysis session after insertion

Secondary outcomes

  1. Achievement of Flow Rates>=450ml/Min at Dialysis Session

    Time frame: flow rate measured at each session; session at 12 months reported

  2. Line Retention (Either/Both Lumens)

    Time frame: 12 months

  3. Infective Episodes (Catheter & Non-catheter Related)

    Time frame: 12 months

  4. Catheter Dysfunction Requiring Use of Thrombolytic Agents

    Time frame: 12 months

  5. Complications at Catheter Insertion

    Time frame: Day 1

  6. Recirculation Rates

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Registry information

Acronym: VyTes

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Dec 1, 2009
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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