Clinical trial NCT06884176: CVCs Versus Midline Catheters
Official title: Complication Rates Associated With Central Venous Catheters Versus Midline Catheters: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Central Venous Catheter
Midline Catheter
Complication of Catheter
Keywords: midline catheter
central venous catheter
central line related bloodstream infection
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Jacobi Medical Center
First posted: 2025-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized to one of two therapies, central venous access or midline
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Prisoner
* 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)

Primary outcomes:
measure: Number of catheter related bloodstream infections (CRBSI) within 28 days of placement
timeFrame: Up to 28 days from placement of catheter
Secondary outcomes:
measure: Number of catheter failures
timeFrame: Up to 28 days from catheter placement
measure: Total number of replacement catheters
timeFrame: Up to 28 days
measure: Total number of upper extremity deep venous thrombosis events
timeFrame: From catheter insertion up to hospital discharge, up to 28 days from catheter insertion.
measure: Number of catheter leakage events
timeFrame: Up to 28 days from catheter placement
measure: Number of catheter infiltration events
timeFrame: Up to 28 days from catheter insertion
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: Jacobi Medical Center, Albert Einstein College of Medicine
name: Sandeep Dhillon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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