CVCs Versus Midline Catheters

NCT06884176 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-16724
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Catheter; Midline Catheter; Complication of Catheter

Keywords

midline catheter; central venous catheter; central line related bloodstream infection

Outcome Measures

Primary Outcomes (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.

  Up to 28 days from placement of catheter

Secondary Outcomes (5)

• 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

Study Arms (2)

central venous catheter

ACTIVE COMPARATOR

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

Device: Ultrasound Guided Central Venous Catheter

Midline catheter

ACTIVE COMPARATOR

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

Device: Ultrasound Guided Midline Catheter

Interventions

Ultrasound Guided Central Venous Catheter DEVICE

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

central venous catheter

Ultrasound Guided Midline Catheter DEVICE

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

Midline catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Jacobi Medical Center: collaborator

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (10)

• 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.

  PMID: 39225710 BACKGROUND

• 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.

  PMID: 29525366 BACKGROUND

• 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.

  PMID: 36751645 BACKGROUND

• 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.

  PMID: 34842905 BACKGROUND

• 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.

  PMID: 33372744 BACKGROUND

• 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.

  PMID: 30886119 BACKGROUND

• 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.

  PMID: 20574104 BACKGROUND

• 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.

  PMID: 20857280 BACKGROUND

• 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.

  PMID: 28979481 BACKGROUND

• 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.

  PMID: 24670166 BACKGROUND

Study Officials

• Sandeep Dhillon, MD

  Jacobi Medical Center, Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariella S Gartenberg, MD

CONTACT

2017871762; ariella.applebaum@gmail.com

Sandeep Dhillon, MD

CONTACT

7189185800; skdhillon91@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized to one of two therapies, central venous access or midline

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• 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)

Locations

US (1)