N/A
N=80
Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters
Hemodialysis
Bottom Line
View on ClinicalTrials.gov: NCT01022359 ↗Enrolled (actual)
80
Serious AEs
8.8%
Results posted
Apr 2021
Primary outcome: Primary: Blood Flow Rate at First Use After Insertion — 277; 383 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TesioCath (Device); LifeCath Twin (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Flow Rate at First Use After Insertion |
277; 383 | — |
| SECONDARY Achievement of Flow Rates>=450ml/Min at Dialysis Session |
361; 379 | — |
| SECONDARY Line Retention (Either/Both Lumens) |
— | — |
| SECONDARY Infective Episodes (Catheter & Non-catheter Related) |
— | — |
| SECONDARY Catheter Dysfunction Requiring Use of Thrombolytic Agents |
0; 6 | — |
| SECONDARY Complications at Catheter Insertion |
0; 0 | — |
| SECONDARY Recirculation Rates |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01022359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.