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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
History of Changes
  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
Haemodialysis
 Device: TesioCath
Device: LifeCath Twin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: October 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022359

Contacts
Contact: Neill Duncan, MBBS MRCP 0044 2083835232 neill.duncan@imperial.nhs.uk
Contact: Albert Power, MBBChir MRCP 0044 2083835256 albert.power@imperial.nhs.uk

Locations
United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Neill Duncan, MBBS MRCP     0044 2083835232     neill.duncan@imperial.nhs.uk    
Contact: Albert Power, MBBChir MRCP     0044 2083835256     albert.power@imperial.nhs.uk    
Principal Investigator: Neill Duncan, MBBS MRCP            
Sub-Investigator: Albert Power, MBBChir MRCP            
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
  More Information

Publications:

Responsible Party: Dr Neill Duncan, Consultant Nephrologist, Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01022359     History of Changes
Other Study ID Numbers: 08/H0710/24
Study First Received: November 30, 2009
Last Updated: July 6, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College Healthcare NHS Trust:
haemodialysis
vascular access
central venous catheter

ClinicalTrials.gov processed this record on May 19, 2013