Hemodialysis
Conditions
Keywords
haemodialysis, vascular access, central venous catheter
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.
Interventions
DEVICETesioCath
Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access
DEVICELifeCath Twin
Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
Sponsors
Imperial College Healthcare NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Flow Rate at First Use After Insertion | First haemodialysis session after insertion |
Secondary
| Measure | Time frame |
|---|---|
| Line Retention (Either/Both Lumens) | 12 months |
| Infective Episodes (Catheter & Non-catheter Related) | 12 months |
| Achievement of Flow Rates>=450ml/Min at Dialysis Session | flow rate measured at each session; session at 12 months reported |
| Complications at Catheter Insertion | Day 1 |
| Recirculation Rates | 12 months |
| Catheter Dysfunction Requiring Use of Thrombolytic Agents | 12 months |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tesio Catheter Patients randomised to receive the established catheter type in use at our centre \[control\]
TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access | 39 |
| LifeCath Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)
LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access | 41 |
| Total | 80 |
Baseline characteristics
| Characteristic | LifeCath | Total | Tesio Catheter |
|---|---|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 16.4 | 61 years STANDARD_DEVIATION 16.1 | 63.3 years STANDARD_DEVIATION 15.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 41 participants | 80 participants | 39 participants |
| Sex: Female, Male Female | 15 Participants | 25 Participants | 10 Participants |
| Sex: Female, Male Male | 26 Participants | 55 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 39 | 4 / 41 |
| other Total, other adverse events | 0 / 39 | 0 / 41 |
| serious Total, serious adverse events | 3 / 39 | 4 / 41 |
Outcome results
Primary
Blood Flow Rate at First Use After Insertion
Time frame: First haemodialysis session after insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tesio Catheter | Blood Flow Rate at First Use After Insertion | 277 mL/min | Standard Deviation 79 |
| LifeCath | Blood Flow Rate at First Use After Insertion | 383 mL/min | Standard Deviation 82 |
Secondary
Achievement of Flow Rates>=450ml/Min at Dialysis Session
Time frame: flow rate measured at each session; session at 12 months reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tesio Catheter | Achievement of Flow Rates>=450ml/Min at Dialysis Session | 361 mL/min | Standard Deviation 48 |
| LifeCath | Achievement of Flow Rates>=450ml/Min at Dialysis Session | 379 mL/min | Standard Deviation 43 |
Secondary
Catheter Dysfunction Requiring Use of Thrombolytic Agents
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tesio Catheter | Catheter Dysfunction Requiring Use of Thrombolytic Agents | 0 thrombolytic infusions |
| LifeCath | Catheter Dysfunction Requiring Use of Thrombolytic Agents | 6 thrombolytic infusions |
Secondary
Complications at Catheter Insertion
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tesio Catheter | Complications at Catheter Insertion | 0 complications at insertion |
| LifeCath | Complications at Catheter Insertion | 0 complications at insertion |
Secondary
Infective Episodes (Catheter & Non-catheter Related)
Time frame: 12 months
Population: measure not collected
Secondary
Line Retention (Either/Both Lumens)
Time frame: 12 months
Population: measure not taken
Secondary
Recirculation Rates
Time frame: 12 months
Population: measure not taken