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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Imperial College Healthcare NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01022359
First received: November 30, 2009
Last updated: July 6, 2010
Last verified: July 2010

November 30, 2009
July 6, 2010
October 2008
January 2011   (final data collection date for primary outcome measure)
Achieving a blood flow rate>=450ml/min at first use after insertion [ Time Frame: First haemodialysis session after insertion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01022359 on ClinicalTrials.gov Archive Site
  • Achievement of flow rates>=450ml/min at each dialysis session [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Line retention (either/both lumens) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Infective episodes (catheter & non-catheter related) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Catheter dysfunction requiring use of thrombolytic agents [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Complications at catheter insertion [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Recirculation rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Haemodialysis
  • Device: TesioCath
    Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access
    Other Name: BioFlex TesioCath (TM) - MedComp, Harleysville, PA, USA
  • 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
  • Active Comparator: Tesio Catheter
    Patients randomised to receive the established catheter type in use at our centre [control]
    Intervention: Device: TesioCath
  • 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)
    Intervention: Device: LifeCath Twin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
January 2012
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Neill Duncan, MBBS MRCP 0044 2083835232 neill.duncan@imperial.nhs.uk
Contact: Albert Power, MBBChir MRCP 0044 2083835256 albert.power@imperial.nhs.uk
United Kingdom
 
NCT01022359
08/H0710/24
No
Dr Neill Duncan, Consultant Nephrologist, Imperial College Healthcare NHS Trust
Imperial College Healthcare NHS Trust
Not Provided
Principal Investigator: Neill Duncan, MBBS MRCP Imperial College Healthcare NHS Trust
Study Director: Albert Power, MBBChir MRCP Imperial College Healthcare NHS Trust
Imperial College Healthcare NHS Trust
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP