NCT06802679: SHUT

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

Completed Phase 4 Last updated 31 January 2025

What this trial tests

Phase 4 trial testing Urokinase in Hemodialysis in 44 participants. Completed in 27 January 2025.

Timeline

1 October 2020

Primary endpoint
4 January 2025

27 January 2025

Quick facts

Lead sponsor	National Healthcare Group, Singapore
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	1 October 2020
Primary completion	4 January 2025
Estimated completion	27 January 2025
Sites	1 location across Singapore

Drugs / interventions tested

• Urokinase — full drug profile →
• Urokinase — full drug profile →

Conditions studied

• Hemodialysis — all drugs for Hemodialysis →
• Thrombolytic Therapy — all drugs for Thrombolytic Therapy →
• Dialysis Access Dysfunction — all drugs for Dialysis Access Dysfunction →
• Randomised Controlled Trial — all drugs for Randomised Controlled Trial →

Sponsor

National Healthcare Group, Singapore

Who can join

21 and older, any sex, with Hemodialysis or Thrombolytic Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.