Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

Hemodialysis Clinical Trial

— VyTes  

Official title:

Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022359
• Other study ID #: 08/H0710/24
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: September 2011

Study information

• Verified date: March 2021
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Device:
• TesioCath
Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access
• LifeCath Twin
Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Duncan ND, Singh S, Cairns TD, Clark M, El-Tayar A, Griffith M, Hakim N, Hamady M, McLean AG, Papalois V, Palmer A, Taube D. Tesio-Caths provide effective and safe long-term vascular access. Nephrol Dial Transplant. 2004 Nov;19(11):2816-22. Epub 2004 Aug 31. — View Citation

Hassell DD 3rd, Vesely TM, Pilgram TK, Audrain JL. Initial performance of Tesio hemodialysis catheters. J Vasc Interv Radiol. 1999 May;10(5):553-8. — View Citation

Perini S, LaBerge JM, Pearl JM, Santiestiban HL, Ives HE, Omachi RS, Graber M, Wilson MW, Marder SR, Don BR, Kerlan RK Jr, Gordon RL. Tesio catheter: radiologically guided placement, mechanical performance, and adequacy of delivered dialysis. Radiology. 2000 Apr;215(1):129-37. — View Citation

Power A, Hill P, Singh SK, Ashby D, Taube D, Duncan N. Comparison of Tesio and LifeCath twin permanent hemodialysis catheters: the VyTes randomized trial. J Vasc Access. 2014 Mar-Apr;15(2):108-15. doi: 10.5301/jva.5000202. Epub 2014 Feb 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Flow Rate at First Use After Insertion		First haemodialysis session after insertion
Secondary	Achievement of Flow Rates>=450ml/Min at Dialysis Session		flow rate measured at each session; session at 12 months reported
Secondary	Line Retention (Either/Both Lumens)		12 months
Secondary	Infective Episodes (Catheter & Non-catheter Related)		12 months
Secondary	Catheter Dysfunction Requiring Use of Thrombolytic Agents		12 months
Secondary	Complications at Catheter Insertion		Day 1
Secondary	Recirculation Rates		12 months