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临床试验/NCT03457259
NCT03457259已完成不适用

The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study

University of Aarhus2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Reducing the use of CVC and PVC

研究概览

简要总结

The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • Admission to the Department of Infectious Disease or Department of Heart Disease.
  • ≥18 years of age
  • Expected requirement for iv. therapy >5 days from the day of enrolment as evaluated by a specialist in infectious diseases.
  • Mentally competency

排除标准

  • Lack of patient consent
  • Requirement for a CVC before study eligibility screening or anticipation of an absolute indication for CVC inserted within 24 hours of screening
  • Personnel for insertion of midline catheter not available

结局指标

主要结局

Reducing the use of CVC and PVC

时间窗: through study completion, an average of 7 month

The fraction of patients requiring either a CVC - including PICC line - or require ≥ 4PVC insertions during the current admittance to the hospital, including follow-up intravenous therapy.

次要结局

  • Patient satisfaction(through study completion, an average of 7 month)
  • Rescue catherizations 2(through study completion, an average of 7 month)
  • Time consumption(through study completion, an average of 7 month)
  • Thrombosis 3(through study completion, an average of 7 month)
  • Catheter discontinuation(through study completion, an average of 7 month)
  • Problems with catheter bloodsampling(through study completion, an average of 7 month)
  • Nurse satisfaction(through study completion, an average of 7 month)
  • Bloodsamples from catheter(through study completion, an average of 7 month)
  • Catheter related infections(through study completion, an average of 7 month)
  • Thrombosis 4(through study completion, an average of 7 month)
  • Bloodsamples (conventional)(through study completion, an average of 7 month)
  • Fluid(through study completion, an average of 7 month)
  • Treatment type(through study completion, an average of 7 month)
  • Painscore(through study completion, an average of 7 month)
  • Thrombosis 1(through study completion, an average of 7 month)
  • Insertion complication 2(through study completion, an average of 7 month)
  • Rescue catherizations 1(through study completion, an average of 7 month)
  • Catheter dwelltime(through study completion, an average of 7 month)
  • Treatment amount(through study completion, an average of 7 month)
  • Thrombosis 2(through study completion, an average of 7 month)
  • Insertion complication 3(through study completion, an average of 7 month)
  • Neuropraxia(through study completion, an average of 7 month)
  • Insertion complication(through study completion, an average of 7 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emma Bundgaard Nielsen

Medical student, Research student

University of Aarhus

研究点 (2)

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