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临床试验/NCT04140916
NCT04140916已完成不适用

Comparison of Two Peripherally Inserted Catheters: a Central Venous and a Midline

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2018年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
304
试验地点
1
主要终点
Number of catheter related blood infection

研究概览

简要总结

Central venous catheters are routinely used, however, with a complication rate exceeding 15%. Therefore, other types of venous catheters have been introduced such as a midline catheter. The purpose of the present study is to assess the efficacy and the safety of midline catheters compared to the standard care being a central catheter also inserted peripherally. Patients with indication for intravenous fluids or medicines for 5 to 28 days will be included in the study.

详细描述

In the United States more than 5 million patients each year get a central venous catheter. Indications for central venous catheterization include infusion of irritant drugs like chemotherapy or total parenteral nutrition, poor peripheral venous access and long term administration of drugs such as antibiotics. This ubiquitous procedure has many associated complications that result in morbidity, mortality, and increased healthcare cost. The overall complication rate is more than 15% and a great preventive effort is done.

Catheter Related Bloodstream Infection (CRBSI) is a serious and feared complication associated with prolonged hospital stays, increased costs and risk of mortality. CRBSI is defined as the presence of bacteremia originating from an intravenous catheter. A lot of effort is done to reduce CRBSI including heightened attention to hygiene in placement and care, improved education and training, and placement of a team with specialized skills. Adherence to best practice for central line placement is shown to reduce risk of CRBSI .

Moreover, central venous catheters (CVCs) are associated with deep vein thrombosis (DVT) and pulmonary embolism. Besides interruption in treatment, catheter-related DVT increases morbidity and mortality. Cancer and admission to intensive care are independent risk factors. Existing data report wide estimates of this adverse outcome, ranging from less than 1% to as high as 38.5%, dependent on the population studied, method of diagnosis, and use of prophylaxis measures.

Peripherally inserted central catheter (PICC) is a CVC which placement and use have been widespread since it was first described in 1975. It is a well-established alternative to CVCs placed via subclavian or jugular veins. It is easy to place, safe and cost-effective compared to others often used central lines. PICC is inserted via a peripheral vein in the upper arm and terminates like other central lines in the vena cava superior. Placement and use is associated with few complications .

Another peripherally inserted catheter is the midline which by definition is 7.5 to 20 centimeters long (3-8 inches) and thus not a CVC. The midline catheter was introduced in 1950s. It has undergone major improvement in material technology and techniques for achieving vascular access. It is inserted in the same peripherally veins as the PICC, but the tip is advanced no further than the distal axillary vein and is therefore classified as a peripheral intravenous catheter with corresponding advantages and disadvantages. The midline cannot be used to vesicants or irritants like most chemotherapy, vasoactive agents, or medications with extremely low or high pH values. The midline is suitable for use from 5 days until 4 weeks to drugs and solutions, which safely can be administrated in a peripheral venous catheter. Severe complication to placement and use of midline is rare, but due to previous problems primarily related to the midline catheter material, its use is limited .

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
Single (Outcomes Assessor)

盲法说明

The statistical analyses of the outcomes will be performed by a statistician being blinded.

入排标准

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

入选标准

  • •Indication for intravenous medicine or fluids included in the following:
  • •Blood products, isotonic saline- or glucose-solutions (including glucose-insulin-potassium-solutions)
  • •Antibiotics (penicillins, cephalosporins, carbapenems or fluoroquinolones)
  • •Chemotherapy registered for use in a peripheral vein catheter
  • •Expected indication for intravenous access in 5 to 28 days
  • •Informed consent

排除标准

  • •Infection or burns at both upper extremities (Involving the area of puncture site)
  • •Pregnancy (Confirmed by positive urine human gonadotropin (hCG) or plasma-hCG)
  • •A central venous catheter already in place (Self-explanatory)
  • •Earlier randomized to the study (Self-explanatory)

研究组 & 干预措施

Midline catheter

Experimental

Insertion of a Midline catheter in patients scheduled for insertion of a catheter for intravenous fluids or medicines with an expected length of treatment between 5 and 28 days will

干预措施: Midline catheter (Device)

PICC-line catheter

Active Comparator

Insertion of a Midline catheter in patients scheduled for insertion of a catheter for intravenous fluids or medicines with an expected length of treatment between 5 and 28 days will

干预措施: PICC-line catheter (Device)

结局指标

主要结局

Number of catheter related blood infection

时间窗: Up to 28 days

Clinical signs of infection (i.e. fever, chills, leukocytosis or hypotension) and at least one positive blood culture.

次要结局

  • Number of catheter leakage(Up to 28 days)
  • Number of deep venous thrombosis(Up to 28 days)
  • Number of catheter failure(Up to 28 days)
  • Score of phlebitis(Up to 28 days)
  • Score of infiltration at the puncture site(Up to 28 days)
  • Score of pain in relation to fluid or drug administration(Up to 28 days)

研究者

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

Bodil Steen Rasmussen

Clinical Professor

Aalborg University Hospital

研究点 (1)

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