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| Name | Class |
|---|---|
| Jacobi Medical Center | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| central venous catheter | Active Comparator | If randomized to this group, patients will receive a triple lumen central venous catheter |
|
| Midline catheter | Active Comparator | If randomized to this group, patients will receive a single lumen midline catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days from catheter placement |
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Inclusion Criteria:
Patients over 18 years of age being treated in the Emergency Department at Jacobi Medical Center
Patients requiring a single vasopressor due to hypotension
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariella S Gartenberg, MD | Contact | 2017871762 | ariella.applebaum@gmail.com | |
| Sandeep Dhillon, MD | Contact | 7189185800 | skdhillon91@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sandeep Dhillon, MD | Jacobi Medical Center, Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39225710 | Background | 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. | |
| 29525366 | 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. |
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Study Protocol
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 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)
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randomized to one of two therapies, central venous access or midline
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| Ultrasound Guided Midline Catheter | Device | Patients randomized to this arm will receive an ultrasound guided midline catheter. The catheter is 8-10cm in length. |
|
| 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). |
| Up to 28 days |
| 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. | From catheter insertion up to hospital discharge, up to 28 days from catheter insertion. |
| 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. | Up to 28 days from catheter placement |
| 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 | Up to 28 days from catheter insertion |
| 36751645 | 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. |
| 34842905 | 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. |
| 33372744 | 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. |
| 30886119 | 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. |
| 20574104 | 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. |
| 20857280 | 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. |
| 28979481 | 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. |
| 24670166 | 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. |