跳至主要内容
临床试验/NCT06802679
NCT06802679已完成4 期

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

National Healthcare Group, Singapore1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年10月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Primary catheter patency, TDC exchange rate for all visits

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

HIgh dose urokinase

Active Comparator

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.

干预措施: Urokinase (Drug)

Standard dose urokinase

Placebo Comparator

same as above but with different dosage of urokinase

干预措施: Urokinase (Drug)

结局指标

主要结局

Primary catheter patency, TDC exchange rate for all visits

时间窗: 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

次要结局

  • Secondary catheter patency, adverse events(6 months)

研究者

发起方
National Healthcare Group, Singapore
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Allen Liu Yan Lun

Senior Consultant

National Healthcare Group, Singapore

研究点 (1)

Loading locations...

相似试验