Evaluation of the Efficacy and Safety of Midline Venous Catheters (MVC)

Central venous catheters are fundamental tools in medical practice, but their use carries frequent local and systemic complications, with bloodstream infection (bacteremia) and thrombus formation being the most frequent and serious. Both complications prolong hospitalization time, increase morbidity, mortality, and hospital costs. Medium access peripheral venous catheters (MC) are a low-cost, easy-to-place, and highly-durable option that offers greater patient comfort and less pain, among other advantages. The objective of this study is to determine if the implementation of a team specialized in the placement of midline (CM) catheters reduces the incidence of infections associated with central venous catheters, decreases the cost of hospitalization, and preserves venous capital in patients admitted to ICU.

Study Overview

• Status: Recruiting
• Conditions: Midline Catheter
• Intervention / Treatment: Device: Catheters comparation

Detailed Description

Central venous catheters are fundamental tools in medical practice, but their use carries frequent local and systemic complications, with bloodstream infection (bacteremia) and thrombus formation being the most frequent and serious. Both complications prolong hospitalization time, increase morbidity, mortality, and hospital costs. Promoting policies to prevent catheter-associated infections (CAIs) not only reduces the number of complications but is also essential to mitigate and control the development of multidrug-resistant organisms. The mechanism by which catheters become colonized is multifactorial and complex. Mainly, bacteria access the catheter through three access routes: 1) migration of superficial organisms that follow the path of the catheter until they colonize its tip. Generally, this extraluminal form of colonization causes bacteremia in the first days of catheterization. 2) The intraluminal route is the most frequent form of colonization. Inadequate cleaning of system connections, especially in multiple-lumen and multiple-path catheters, allows bacteria to enter after the first week of use. The third colonization route is rare and is due to hematogenous seeding of bacteria from a distant focus of infection or intrinsic contamination of the infused fluid. Other factors that also favor catheter colonization are the type of material (Teflon is less friendly to the vein), the number of lumens (directly proportional to the risk of infection), the nutritional and immunological deterioration of the individual, the type of infusion administered and the insertion site.

Medium access peripheral venous catheters (MC) are a low-cost, easy-to-place, and highly-durable option that offers greater patient comfort and less pain, among other advantages. They are placed using the Seldinger surgical technique at the foot of the bed, in a simple manner, and under ultrasound guidance. The catheter enters through a peripheral vein near the elbow crease and its tip is positioned at the level of the axillary vein, facilitating the infusion of drugs with an osmolarity <600 mOsm, pH range of 5 to 9, and blood derivatives. The success rate of the procedure is almost 100%, particularly if an expert performs the catheterization.

Midline catheters are an intermediate type of catheter between peripheral and central lines. This makes them a suitable choice for patients who are chronically hospitalized in intensive care units.

The benefits of midline catheters include a longer duration of use compared to peripheral catheters (up to 28 days), a lower incidence of procedure-related complications such as pneumothorax and infections and thrombosis compared to central lines. Moreover, they enable early removal of central lines and can be a viable option for patients with challenging vascular access, aiding in the preservation of venous reserve, which is often disregarded. These factors suggest that their use can result in decreased hospital costs. Unlike centrally inserted catheters, which require a physician's intervention for placement and removal, midline catheters can be inserted and removed by nursing professionals.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Nestor Pistillo, MD; Phone Number: 3507 42109000; Email: nestor.pistillo@hospitalelcruce.org
• Study Contact Backup: Name: Lucia Duarte, BSN; Phone Number: 42109000; Email: lucymduarte1982@gmail.com

Study Locations

• Argentina
  • Buenos Aires
    • Florencio Varela, Buenos Aires, Argentina, 1888
      • Recruiting
      • Hospital El Cruce
      • Contact: Néstor Pistillo, MD; Phone Number: +5401142109000; Email: néstor.pistillo@hospitalelcruce.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with prolonged hospitalization in ICU (>10 days)

Description

Inclusion Criteria: Patients with prolonged hospitalization in ICU

-

Exclusion Criteria:

1. Pregnant women and terminal patients.
2. Skin infection at the site at the insertion site.
3. Central vascular occlusions, including patients with pacemakers.
4. Fistula for dialysis.
5. Mastectomy and lymphedema.
6. Positive blood cultures at the time of placement.
7. Coagulation disorders.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infection reduction	Assessment of incidence of complications associated with midline catheters	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thrombosis reduction	Assessment of incidence of complications associated with midline catheters	1 year

Collaborators and Investigators

• Sponsor: Hospital El Cruce
• Investigators: Study Director: Maximiliano Paz, BSN, Hospital El Cruce

Publications and helpful links

General Publications

• Adams DZ, Little A, Vinsant C, Khandelwal S. The Midline Catheter: A Clinical Review. J Emerg Med. 2016 Sep;51(3):252-8. doi: 10.1016/j.jemermed.2016.05.029. Epub 2016 Jul 5.
• Zheng WM. Some exact results and approximations for cluster growth on the Cayley tree. Phys Rev A Gen Phys. 1987 Dec 15;36(12):5851-5853. doi: 10.1103/physreva.36.5851. No abstract available.
• Hadaway L, Mermel LA. Midline Catheters: Could They Replace a Central Vascular Access Device? J Infus Nurs. 2022 Jul-Aug 01;45(4):220-224. doi: 10.1097/NAN.0000000000000471.
• Terrault NA, Zhou S, Combs C, Hahn JA, Lake JR, Roberts JP, Ascher NL, Wright TL. Prophylaxis in liver transplant recipients using a fixed dosing schedule of hepatitis B immunoglobulin. Hepatology. 1996 Dec;24(6):1327-33. doi: 10.1002/hep.510240601.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: infusion therapy
• Other Study ID Numbers: 026/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No