Comparison of Standard Versus High Dose Urokinase for Dysfunctional Tunneled Dialysis Catheters in Haemodialysis Patients: a Randomized Controlled Trial (SHUT)

January 26, 2025 updated by: Allen Liu Yan Lun, National Healthcare Group, Singapore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 768828
        • Khoo Teck Puat Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  • Patients with TDC non-function, defined as no inflow and outflow from both arterial and venous ports upon catheter testing.
  • Patients with contraindications to Urokinase including active internal bleeding; recent cerebrovascular accident (< 2 months); recent intracranial or intraspinal surgery (< 2 months); intracranial neoplasm, aneurysm or arteriovenous malformation; recent trauma, including cardiopulmonary resuscitation; recent gastrointestinal bleeding (<2 months); known bleeding diathesis; severe uncontrolled hypertension; known hypersensitivity to Urokinase or any ingredient present in its formulation.
  • Pregnancy.
  • Tunneled dialysis catheter-related blood stream infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HIgh dose urokinase

Patients will be assessed for eligibility for study by nephrologist on duty who is also a PI or Co-I.

Patients who meet inclusion criteria will be enrolled in study and informed consent taken.

A trained HD nurse will test the catheter of the patient presenting with TDC dysfunction.

Once TDC dysfunction is confirmed, patients will be randomized to one of 2 groups and urokinase instillation done according to protocol (see section F9) After a minimum dwell time of 2 hours, urokinase is aspirated and catheter tested by a trained HD nurse. Haemodialysis is then carried out via the catheter.

Baseline clinical data, urokinase and hemodialysis details will be recorded for each patient visit as per data collection template.
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.
Other Names:
  • High dose urokinase
Drug: Urokinase
20,000unit (1ml) is instilled per catheter lumen (in both arterial and venous ports respectively); and the remaining 1ml is discarded.
Other Names:
  • Standard dose urokinase
Placebo Comparator: Standard dose urokinase
same as above but with different dosage of urokinase
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.
Other Names:
  • High dose urokinase
Drug: Urokinase
20,000unit (1ml) is instilled per catheter lumen (in both arterial and venous ports respectively); and the remaining 1ml is discarded.
Other Names:
  • Standard dose urokinase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary catheter patency, TDC exchange rate for all visits
Time Frame: 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary catheter patency, adverse events
Time Frame: 6 months
Secondary patency: Interval between second episode of dysfunction until TDC exchange / removal or other censorship event achieved (death, change of modality)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Healthcare Group, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

January 4, 2025

Study Completion (Actual)

January 27, 2025

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

January 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHEG2007
  • Comparison of Standard versus (Other Grant/Funding Number: Alexandra Health Fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodialysis

Clinical Trials on Urokinase

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe