CVCs Versus Midline Catheters

April 1, 2026 updated by: Albert Einstein College of Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10461
        • Jacobi Medical Center
        • Contact:
        • Principal Investigator:
          • Sandeep Dhillon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: central venous catheter
If randomized to this group, patients will receive a triple lumen central venous catheter
Device: Ultrasound Guided Central Venous Catheter
Patients randomized to this arm will receive an ultrasound guided central venous catheter. The catheter is 20cm in length.
Active Comparator: Midline catheter
If randomized to this group, patients will receive a single lumen midline catheter
Device: Ultrasound Guided Midline Catheter
Patients randomized to this arm will receive an ultrasound guided midline catheter. The catheter is 8-10cm in length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of catheter related bloodstream infections (CRBSI) within 28 days of placement
Time Frame: 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.
Up to 28 days from placement of catheter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of catheter failures
Time Frame: Up to 28 days from catheter placement
Any mechanical failures (accidental withdrawal or dislodgement, breakage, occlusion) will be documented. The total number of mechanical failures will be recorded, 1 or more per patient, by study arm. The type of mechanical failures will not be itemized.
Up to 28 days from catheter placement
Total number of replacement catheters
Time Frame: Up to 28 days
The total number of replacement IV catheters required will be documented. This will be assessed based on each study arm (midline and central line).
Up to 28 days
Total number of upper extremity deep venous thrombosis events
Time Frame: From catheter insertion up to hospital discharge, up to 28 days from catheter insertion.
This is defined as symptomatic or asymptomatic DVT, verified by ultrasound or computed tomography. The total number of upper extremity DVT events will be recorded by study arm.
From catheter insertion up to hospital discharge, up to 28 days from catheter insertion.
Number of catheter leakage events
Time Frame: Up to 28 days from catheter placement
Catheter leakage events is defined as leakage of blood or fluids from the puncture site. The total number of catheter leakage events will be recorded by study arm.
Up to 28 days from catheter placement
Number of catheter infiltration events
Time Frame: Up to 28 days from catheter insertion
Catheter infiltration events is defined as infiltration/swelling or pain around the insertion site with medication or fluid administration. The total number of catheter infiltration events will be recorded by study arm
Up to 28 days from catheter insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

Jacobi Medical Center

Investigators

  • Principal Investigator: Sandeep Dhillon, MD, Jacobi Medical Center, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-16724

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol

IPD Sharing Time Frame

Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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