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临床试验/NCT05707936
NCT05707936尚未招募不适用

Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath: Randomized Controlled Trial

Chang Gung Memorial Hospital0 个研究点目标入组 192 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
192
主要终点
port-a-cath infection

研究概览

简要总结

Purpose:

An evidence implementation of a randomized controlled trial for whether there is the difference in intermittent flushing 0.9% normal saline and heparin? Design: a single-blind randomized controlled trial

Method:

This study is based on the 5A (Ask, Acquire, Appraise, Apply, Audit) of evidence health care step, and design randomized controlled trial for evidence implementation.

We will include inpatients over 20 years-old adults in New Taipei City TuCheng Hospital, Taiwan, who need administration medicine by port-a-catcher. The sample size is 192 according to G-power software. Random allocation software has using for block randomization, would assign to group A: flushing with 0.9% normal saline 10ml, group B: flushing with 0.9% normal saline 20ml, and group C: flushing with heparin 100 USP/ml. SPSS 20.0 software for statistical analysis, mean or standard deviation, one- way ANOVA would use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Non-pediatric inpatients over 20 years of age with PAC placed for any disease and who need medication during hospitalization.

排除标准

  • History of PAC obstruction, continuous high volume drip via PAC, taking anticoagulant or antiplatelet agents, abnormal blood coagulation, pregnancy or contraceptive use, specified flushing solution by case

研究组 & 干预措施

Normal saline 10 ml

Experimental

干预措施: Normal Saline Flush 10 ml (Drug)

Normal saline 20 ml

Experimental

干预措施: Normal Saline Flush 20 ml (Drug)

usual care (heparin)

Active Comparator

干预措施: Heparin Flush (1000 USP, 10ml) (Drug)

结局指标

主要结局

port-a-cath infection

时间窗: in hospitalized (during admission), up to 12 weeks

blood culture from port-A show bacterial growth

port-a-cath occlusion

时间窗: in hospitalized (during admission), up to 12 weeks

failure to infusion fluid

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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