CVCs Versus Midline Catheters

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Ultrasound Guided Central Venous Catheter
  Patients randomized to this arm will receive an ultrasound guided central venous catheter. The catheter is 20cm in length.
• Устройство Ultrasound Guided Midline Catheter
  Patients randomized to this arm will receive an ultrasound guided midline catheter. The catheter is 8-10cm in length.

Первичные конечные точки

• Number of catheter related bloodstream infections (CRBSI) within 28 days of placement [Срок оценки: Up to 28 days from placement of catheter]

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Jacobi Medical Center — The Bronx

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06884176 · 2025-16724

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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