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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01022359
First Posted: December 1, 2009
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust
  Purpose
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.

Condition Intervention
Hemodialysis Device: TesioCath Device: LifeCath Twin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

Resource links provided by NLM:


Further study details as provided by Imperial College Healthcare NHS Trust:

Primary Outcome Measures:
  • Achieving a blood flow rate>=450ml/min at first use after insertion [ Time Frame: First haemodialysis session after insertion ]

Secondary Outcome Measures:
  • Achievement of flow rates>=450ml/min at each dialysis session [ Time Frame: 12 months ]
  • Line retention (either/both lumens) [ Time Frame: 12 months ]
  • Infective episodes (catheter & non-catheter related) [ Time Frame: 12 months ]
  • Catheter dysfunction requiring use of thrombolytic agents [ Time Frame: 12 months ]
  • Complications at catheter insertion [ Time Frame: Day 1 ]
  • Recirculation rates [ Time Frame: 12 months ]

Enrollment: 80
Study Start Date: October 2008
Study Completion Date: September 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tesio Catheter
Patients randomised to receive the established catheter type in use at our centre [control]
Device: TesioCath
Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access
Other Name: BioFlex TesioCath (TM) - MedComp, Harleysville, PA, USA
Active Comparator: LifeCath
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
Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
Other Name: Vygon LifeCath Twin - Vygon(UK) Ltd, Cirencester, Gloucs, UK

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022359


Locations
United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Investigators
Principal Investigator: Neill Duncan, MBBS MRCP Imperial College Healthcare NHS Trust
Study Director: Albert Power, MBBChir MRCP Imperial College Healthcare NHS Trust