Clinical trial NCT01022359: Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters
Official title: Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: haemodialysis
vascular access
central venous catheter
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Blood Flow Rate at First Use After Insertion
timeFrame: First haemodialysis session after insertion
Secondary outcomes:
measure: Achievement of Flow Rates>=450ml/Min at Dialysis Session
timeFrame: flow rate measured at each session; session at 12 months reported
measure: Line Retention (Either/Both Lumens)
timeFrame: 12 months
measure: Infective Episodes (Catheter & Non-catheter Related)
timeFrame: 12 months
measure: Catheter Dysfunction Requiring Use of Thrombolytic Agents
timeFrame: 12 months
measure: Complications at Catheter Insertion
timeFrame: Day 1
measure: Recirculation Rates
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Neill Duncan, MBBS MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College Healthcare NHS Trust
name: Albert Power, MBBChir MRCP
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1093/ndt/gfh467. Epub 2004 Aug 31.
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. doi: 10.1148/radiology.215.1.r00mr43129.
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. doi: 10.1016/s1051-0443(99)70082-5.
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.