NCT06802679

Comparison of Standard Versus High Dose Urokinase for Dysfunctional Tunneled Dialysis Catheters in Haemodialysis Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Healthcare Group, Singapore · Other Government
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis
• Thrombolytic Therapy
• Dialysis Access Dysfunction
• Randomised Controlled Trial
• End Stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DRUG	Urokinase	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.
DRUG	Urokinase	20,000unit (1ml) is instilled per catheter lumen (in both arterial and venous ports respectively); and the remaining 1ml is discarded.

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-01-04
• Completion: 2025-01-27
• First posted: 2025-01-31
• Last updated: 2025-01-31

Locations

1 site across 1 country: Singapore