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临床试验/NCT02868697
NCT02868697已完成4 期

Management of Tunneled Catheter Thrombosis in Hemodialysis Patients: Prospective Study From Qatar

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
170
试验地点
1
主要终点
Number of catheter thrombosis episodes

研究概览

简要总结

Goal of the study:

A- To find out the best protocol for catheter lock solution to decrease the prevalence of catheter thrombosis

    • The time to first episode of catheter thrombosis lead to catheter change.
    • Number of acute episode of thrombosis that interrupt dialysis
    • Median Survival life of the catheter in both groups after adjusting it to the outcome.

B- Specific Objective: To evaluate the cost effectiveness by measure

1- Amount of r-TPA used in each group to treatment acute catheter thrombosis 2- Number of catheter exchange in both group 3- Hospitalization days related to catheter malfunctioning or CRI in each group 4- Type and days of antibiotics 5- Cost of the treatment in each group

c- Secondary Objective:

To correlate the result of two catheters lock solution protocols with the published data using r-TPA instead of heparin once week as compared with heparin 3 times per week as a locking solution.

详细描述

This prospective single blind randomized controlled study. All patients who undergoing tunneled catheter regular hemodialysis in the three hemodialysis units and meet the inclusion criteria will be included in the study.

Signed informed consent will be taken from all patients or their first authorized relative.

All patients will be randomized on 1:1 basis using computer-generated program.Patients will be randomly assigned to lock the catheter post HD either with 1.35% taurolidine citrate (2H-1,2,4-thiadiazine-4,4'-methylenebis[tetrahydro-1,1,1',1'-tetraoxide], 4% citrate and 500 IU/ml heparin (TauroLock Hep500) (TauroPharmGmbH, www.tauropharm.de) at the end of of all Hemodialysis sessions and during all interdialytic periods or after the first two session only per week and during first two interdialytic periods then taurolidine citrate, 4% citrate /25000 IU unit urokinase (TauroLock U25000) at the end of third session before week end, (over the week end). The assigned nurse will flush the catheter after each session with 20 mL of saline then instill TauroLock according to the filling volume of the catheter. Before starting the next dialysis the lock solution has to be aspirated and discarded. Acute catheter thrombosis which interrupt the dialysis will be treated with r-TPA according to unit protocol, if this happen for three consecutive HD we will consider it as malfunction and we will refer it for catheter exchange . Any catheter will be referred to the vascular surgeon for exchange; we will not continue calculating its days as there might be a gap between referral's time and catheter exchange due admission problems. If the catheter is replaced, patient will continue on the same arm of the study.

Control Group:

We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of of all Hemodialysis sessions and during all interdialytic periods.

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
Single (Participant)

入排标准

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

入选标准

  • 1- Adult patients aged>14 years 2- Undergoing HD through tunneled HD 3- Recently inserted or old tunneled catheter 4- Blood flow rate at the beginning of the study≥ 300ml/min

排除标准

  • 1- Malfunctioning catheter defined by blood flow rate < 300ml/min 2- Known patient to have allergy to drug medication 3- Major Hemorrhage in previous 4 week

研究组 & 干预措施

A

Active Comparator

We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of of all Hemodialysis sessions and during all interdialytic periods

干预措施: (TauroLock Hep500) (Drug)

B

Experimental

We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of the first two session only per week and during first two interdialytic periods then TauroLock U 25000at the end of third session before week end, (over the week end).

干预措施: TauroLock U 25000 (Drug)

结局指标

主要结局

Number of catheter thrombosis episodes

时间窗: 6 months per patient

The time to first episode of catheter thrombosis lead to catheter change. Number of acute episode of thrombosis that interrupt dialysis Median Survival life of the catheter in both groups after adjusting it to the outcome.

次要结局

  • Hospitalization days related to catheter malfunctioning or CRI in each group(6 months)
  • Amount of r-TPA used in each group for treatment of acute catheter thrombosis(6 months)
  • Number of catheter exchange in each group(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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