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Central Venous CatheterNCT06884176

CVCs Versus Midline Catheters

A study testing Ultrasound Guided Central Venous Catheter and Ultrasound Guided Midline Catheter in people with Central Venous Catheter and Midline Catheter, run by Albert Einstein College of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ultrasound Guided Central Venous Catheter and Ultrasound Guided Midline Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2026to Jun 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

About this study

Official title: 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.

Read the 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.

Being tested
Ultrasound Guided Central Venous Catheter, Ultrasound Guided Midline Catheter
Keywords
midline catheter, central venous catheter, central line related bloodstream infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound Guided Central Venous CatheterDevice

    Patients randomized to this arm will receive an ultrasound guided central venous catheter. The catheter is 20cm in length.

  • Ultrasound Guided Midline CatheterDevice

    Patients randomized to this arm will receive an ultrasound guided midline catheter. The catheter is 8-10cm in length.

Study groups in NCT06884176
Study groupRoleWhat they receive
central venous catheterActive comparatorIf randomized to this group, patients will receive a triple lumen central venous catheter
Receives: Device: Ultrasound Guided Central Venous Catheter
Midline catheterActive comparatorIf randomized to this group, patients will receive a single lumen midline catheter
Receives: Device: Ultrasound Guided Midline Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Up to 28 days from placement of catheter

Secondary outcomes (5)
  1. Number of catheter failures

    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.

    Measured: Up to 28 days from catheter placement

  2. Total number of replacement catheters

    The total number of replacement IV catheters required will be documented. This will be assessed based on each study arm (midline and central line).

    Measured: Up to 28 days

  3. Total number of upper extremity deep venous thrombosis events

    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.

    Measured: From catheter insertion up to hospital discharge, up to 28 days from catheter insertion.

  4. Number of catheter leakage events

    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.

    Measured: Up to 28 days from catheter placement

  5. Number of catheter infiltration events

    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

    Measured: Up to 28 days from catheter insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Why it stopped: After several revisions, study was never approved by the local ethics board.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized to one of two therapies, central venous access or midline
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06884176
Sponsor's protocol ID
2025-16724
Other IDs
2025
Status last verified
Aug 2026
First submitted
13 Mar 2025
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Study Protocol

Publications

  • Li X, Zhang H, Li H, Sun W. Comparison of complications and indwelling time in midline catheters versus central venous catheters: A systematic review and meta-analysis. Int J Nurs Pract. 2024 Dec;30(6):e13301. doi: 10.1111/ijn.13301. Epub 2024 Sep 3.

    PubMed 39225710
  • Mushtaq A, Navalkele B, Kaur M, Krishna A, Saleem A, Rana N, Gera S, Chandramohan S, Surapaneni M, Chopra T. Comparison of complications in midlines versus central venous catheters: Are midlines safer than central venous lines? Am J Infect Control. 2018 Jul;46(7):788-792. doi: 10.1016/j.ajic.2018.01.006. Epub 2018 Mar 7.

    PubMed 29525366
  • Urtecho M, Torres Roldan VD, Nayfeh T, Espinoza Suarez NR, Ranganath N, Sampathkumar P, Chopra V, Safdar N, Prokop LJ, O'Horo JC. Comparing Complication Rates of Midline Catheter vs Peripherally Inserted Central Catheter. A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2023 Jan 18;10(2):ofad024. doi: 10.1093/ofid/ofad024. eCollection 2023 Feb.

    PubMed 36751645
  • Swaminathan L, Flanders S, Horowitz J, Zhang Q, O'Malley M, Chopra V. Safety and Outcomes of Midline Catheters vs Peripherally Inserted Central Catheters for Patients With Short-term Indications: A Multicenter Study. JAMA Intern Med. 2022 Jan 1;182(1):50-58. doi: 10.1001/jamainternmed.2021.6844.

    PubMed 34842905
  • Tripathi S, Kumar S, Kaushik S. The Practice and Complications of Midline Catheters: A Systematic Review. Crit Care Med. 2021 Feb 1;49(2):e140-e150. doi: 10.1097/CCM.0000000000004764.

    PubMed 33372744
  • Chopra V, Kaatz S, Swaminathan L, Boldenow T, Snyder A, Burris R, Bernstein SJ, Flanders S. Variation in use and outcomes related to midline catheters: results from a multicentre pilot study. BMJ Qual Saf. 2019 Sep;28(9):714-720. doi: 10.1136/bmjqs-2018-008554. Epub 2019 Mar 18.

    PubMed 30886119
  • Trerotola SO, Stavropoulos SW, Mondschein JI, Patel AA, Fishman N, Fuchs B, Kolansky DM, Kasner S, Pryor J, Chittams J. Triple-lumen peripherally inserted central catheter in patients in the critical care unit: prospective evaluation. Radiology. 2010 Jul;256(1):312-20. doi: 10.1148/radiol.10091860.

    PubMed 20574104
  • Bonizzoli M, Batacchi S, Cianchi G, Zagli G, Lapi F, Tucci V, Martini G, Di Valvasone S, Peris A. Peripherally inserted central venous catheters and central venous catheters related thrombosis in post-critical patients. Intensive Care Med. 2011 Feb;37(2):284-9. doi: 10.1007/s00134-010-2043-x. Epub 2010 Sep 21.

    PubMed 20857280
  • Wall C, Moore J, Thachil J. Catheter-related thrombosis: A practical approach. J Intensive Care Soc. 2016 May;17(2):160-167. doi: 10.1177/1751143715618683. Epub 2015 Dec 3.

    PubMed 28979481
  • Magill SS, Edwards JR, Bamberg W, Beldavs ZG, Dumyati G, Kainer MA, Lynfield R, Maloney M, McAllister-Hollod L, Nadle J, Ray SM, Thompson DL, Wilson LE, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Multistate point-prevalence survey of health care-associated infections. N Engl J Med. 2014 Mar 27;370(13):1198-208. doi: 10.1056/NEJMoa1306801.

    PubMed 24670166

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound Guided Central Venous Catheter and Ultrasound Guided Midline Catheter in people with Central Venous Catheter and Midline Catheter, run by Albert Einstein College of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of catheter related bloodstream infections (CRBSI) within 28 days of placement (time frame: Up to 28 days from placement of catheter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06884176, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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