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临床试验/NCT06884176
NCT06884176撤回不适用

Complication Rates Associated With Central Venous Catheters Versus Midline Catheters: A Randomized Control Trial

Albert Einstein College of Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
100
试验地点
1
主要终点
Number of catheter related bloodstream infections (CRBSI) within 28 days of placement

研究概览

简要总结

The goal of this clinical trial is to learn if midline catheters can reduce adverse patient outcomes in adult patients requiring a single vasopressor. The main questions the study aims to answer are:

  • Do midline catheters reduce the rates of catheter-related bloodstream infections as compared to central venous catheters?
  • Do midline catheters reduce the rates of deep venous thrombosis as compared to central venous catheters? Researchers will compare midline catheters to central venous catheters to see if there is a reduction in these events.

Participants will be randomized to the midline catheter group or the central venous catheter group. The catheters will be part of standard of care for vasopressor therapy. The participants will be followed for 30 days.

详细描述

Within the United States, around 5 million central venous catheters (CVCs) and 150 million peripheral catheters are inserted annually. A 2015 surveillance survey across 10 U.S. states revealed that 4% of hospitalized patients had 1 or more healthcare-associated infections, with 25.6% reported as device-associated infections. Device-associated infections included catheter-related bloodstream infection (CRBSI), catheter-associated urinary tract infections, and ventilator-associated pneumonia. In addition to increased rates of CRBSI, CVCs are associated with upper extremity deep venous thrombosis (DVT). Peripherally inserted central catheters (PICCs) have previously been proposed as an alternative to CVCs to avoid these complications. However, due to the increasing lumen diameter of PICCs, increased rates of catheter-related thrombosis as compared to CVCs have been reported. In contrast to PICCs where the catheter tip ends at the cavo-atrial junction near the right atrium, midline catheters are peripheral vascular devices inserted into the upper extremity veins that terminate at or below the axillary vein. As midlines terminate prior to the large vasculature of the chest, studies have demonstrated lower rates of CRBSI or DVTs as compared to the reported incidence of such complications with PICCs or CVCs. To date, there have been no large-scale randomized control trials comparing CVC and midline complication rates, including thrombosis, CRBSI, central-line associated readmission, and overall patient mortality.

The authors plan to conduct a parallel, 2-group, open-label randomized control trial at a single urban academic center. A convenience sample of adult patients will be obtained over the course of 1 year. Patients with single vasopressor requirements will be subject to enrollment. Patients will be enrolled in the study by clinicians participating in their care who are involved in the placement of the catheter (midline or CVC). Informed consent will take place in the emergency department (ED) prior to the catheter placement. Clinicians will ask patients who are being treated whether they are interested in the study. Study team members will then approach interested patients to obtain consent for the research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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 over 18 years of age being treated in the Emergency Department at Jacobi Medical Center
  • Have an upper extremity (left or right arm) that can accept a midline catheter
  • Able to provide consent (patient or health care proxy)
  • Clinical team believes the patient will require inpatient admission at the time of needing intravenous access
  • Requires a central line or midline catheter as an expected requirement of care
  • Patients requiring a single vasopressor due to hypotension

排除标准

  • Patients in cardiac arrest (prior to achieving ROSC)
  • Patients with infection or burns at both upper extremities
  • Patient expected to be discharged from the hospital within 24 hours
  • Pregnancy
  • Children less than 18 years of age
  • The patient is known or is suspected to be allergic to materials contained in the device
  • Patients known to have bacteremia
  • Patients with existing central venous catheter
  • Patients without the ability to consent (or no health care proxy to consent)

研究组 & 干预措施

central venous catheter

Active Comparator

If randomized to this group, patients will receive a triple lumen central venous catheter

干预措施: Ultrasound Guided Central Venous Catheter (Device)

Midline catheter

Active Comparator

If randomized to this group, patients will receive a single lumen midline catheter

干预措施: Ultrasound Guided Midline Catheter (Device)

结局指标

主要结局

Number of catheter related bloodstream infections (CRBSI) within 28 days of placement

时间窗: Up to 28 days from placement of catheter

The number of CRBSIs will be determined by clinical signs of infection (i.e., fever, chills, leukocytosis or hypotension) and at least one positive blood culture within 28 days of placement of catheter. The total number of CRBSIs will be recorded per study arm.

次要结局

  • Number of catheter failures(Up to 28 days from catheter placement)
  • Total number of replacement catheters(Up to 28 days)
  • Total number of upper extremity deep venous thrombosis events(From catheter insertion up to hospital discharge, up to 28 days from catheter insertion.)
  • Number of catheter leakage events(Up to 28 days from catheter placement)
  • Number of catheter infiltration events(Up to 28 days from catheter insertion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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