Hemodialysis, Thrombolytic Therapy, Dialysis Access Dysfunction, Randomised Controlled Trial, End Stage Renal Disease (ESRD)
Conditions
Keywords
urokinase
Brief summary
Tunneled dialysis catheters (TDCs) remain a frequent form of vascular access for patients undergoing long-term haemodialysis (HD). In our local setting, thrombolytic therapy with urokinase is used as first line therapy to restore catheter patency in patients who develop TDC dysfunction before considering a TDC exchange which is more invasive, requires hospital admission, and involves a higher cost. There are no published local data on the efficacy of Urokinase, though this is widely used in local practice as first line in the management of TDC dysfunction. Previous studies have also varied in terms of study methodology, dose and administration of urokinase in the form of systemic infusion or catheter lock therapy, with varying success rates of 78-97% (2,4-8). Overall, majority of these studies utilized higher doses of urokinase - some studies reported higher patency rates with high dose systemic infusion (4,5) or higher success rates when a higher dose was compared to a lower dose of urokinase lock (6-8). Bleeding events were very rare even in studies that use much higher doses or systemic infusion of urokinase (2,4-8). Our own preliminary data show lower lower success rates of around 52.5% compared to published reports, the question remains on how we can improve our patency rate and cost-effectiveness in treating TDC dysfunction without an increase in risk of adverse events. Therefore, we aim to answer the question as to whether an increase in dose of urokinase will achieve the above outcomes and result in a reduced need for TDC exchange.
Interventions
DRUGUrokinase
In the higher dose group: 30,000unit (1.5ml) per catheter lumen is instilled per catheter lumen (in both arterial and venous ports respectively). This allows utilization of the entire vial of Urokinase to prevent wastage and to assess if this increase in dose improves catheter patency and survival, thus reducing the need for a TDC exchange in our HD patients. The urokinase lock is dwelled for at least 2 hours, after which aspiration and catheter testing will be done by a trained HD nurse.
Sponsors
National Healthcare Group, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All HD patients aged 21 or above with TDC dysfunction and able to provide informed consent and do not meet any
Exclusion criteria
are eligible for enrolment in the study. Catheters eligible for the study include: (i) Incident catheters that have never received urokinase; including newly inserted catheters for previously enrolled patients are allowed. (ii) Prevalent catheters that have not received urokinase for the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary catheter patency, TDC exchange rate for all visits | 6 months | Catheter patency right after urokinase aspiration as tested by trained HD nurse (complete / partial / failed) for each patient visit. Primary patency: Interval between primary intervention (high versus standard dose urokinase) and repeated intervention for recurring dysfunction in a catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary catheter patency, adverse events | 6 months | Secondary patency: Interval between second episode of dysfunction until TDC exchange / removal or other censorship event achieved (death, change of modality) |
Countries
Singapore
Outcome results
None listed