跳至主要内容
临床试验/NCT02970409
NCT02970409已完成不适用

A Randomized Study to Test Peripheral Venous Catheter Lock Therapy With Either Heparin or Saline in Patients Admitted to the Internal Medicine Department

Hospital General Universitario Gregorio Marañon2 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2015年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
354
试验地点
2
主要终点
complications

研究概览

简要总结

A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter. Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

详细描述

The need of use of peripheral venous catheters and the importance of a proper management to avoid catheter colonization or phlebitis requires two possible preventive approaches: lock therapy with heparin or saline.

Heparin demonstrated its efficacy in central venous catheters, but there are still controversies of whether it is useful in peripheral venous catheters.

Objectives To compare the efficacy of heparin in peripheral venous catheters lock versus saline for the prevention of colonization and phlebitis in patients admitted to an Internal Medicine Department.

Methods: A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter.

Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

研究设计

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

入排标准

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

入选标准

  • patients with inserted PV Catheter within 24h from admission in internal medicine

排除标准

  • hypersensibility to heparin
  • active hemorrhage
  • coagulation alterations

结局指标

主要结局

complications

时间窗: Daily from catheter insertion until catheter withdraw(estimated 10 days)

prevention of colonization(superficial and tip culture) and phlebitis(visual inflammation of entrance of catheter insertion) .

次要结局

  • catheter related infection rate(Through study completion( estimated 2 year after Last patient in))
  • adverse events(number of catheter obstructions and coagulation alterations)(Through study completion (2 year afterLast patient in))

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Sponsor

研究点 (2)

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