| Trial ID: | L1565 |
| Source ID: | NCT06802679
|
| Associated Drug: |
Urokinase
|
| Title: |
Comparison of Standard Versus High Dose Urokinase for Dysfunctional Tunneled Dialysis Catheters in Haemodialysis Patients: a Randomized Controlled Trial
|
| Acronym: |
SHUT
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hemodialysis|Thrombolytic Therapy|Dialysis Access Dysfunction|Randomised Controlled Trial|End Stage Renal Disease (ESRD)
|
| Interventions: |
DRUG: Urokinase|DRUG: Urokinase
|
| Outcome Measures: |
Primary: Primary catheter patency, TDC exchange rate for all visits, 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: Secondary catheter patency, adverse events, Secondary patency: Interval between second episode of dysfunction until TDC exchange / removal or other censorship event achieved (death, change of modality), 6 months
|
| Sponsor/Collaborators: |
Sponsor: National Healthcare Group, Singapore
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-10-01
|
| Completion Date: |
2025-01-27
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-31
|
| Locations: |
Khoo Teck Puat Hospital, Singapore, 768828, Singapore
|
| URL: |
https://clinicaltrials.gov/show/NCT06802679
|
