Evaluation of the Efficacy and Safety of Midline Venous Catheters

NCT05835531 | Unknown DMC

• 1 other identifier: 026/2022
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Midline Catheter

Keywords

infusion therapy

Outcome Measures

Primary Outcomes (1)

• infection reduction

  Assessment of incidence of complications associated with midline catheters

  1 year

Secondary Outcomes (1)

• thrombosis reduction

  1 year

Interventions

Catheters comparation DEVICE

Assessment of incidence of complications associated with midline catheters

Also known as: MIDLINE VENOUS CATHETERS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with prolonged hospitalization in ICU (\>10 days)

You may not qualify if:

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

Sponsors & Collaborators

• Hospital El Cruce: lead

Study Sites (1)

Hospital El Cruce

San Juan Bautista, Buenos Aires, 1888, Argentina

RECRUITING

Related Publications (4)

• 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.

  PMID: 27397766 BACKGROUND

• 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.

  PMID: 9898877 BACKGROUND

• 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.

  PMID: 35820127 BACKGROUND

• 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.

  PMID: 8938155 BACKGROUND

Study Officials

• Maximiliano Paz, BSN

  Hospital El Cruce

  STUDY DIRECTOR

Central Study Contacts

Nestor Pistillo, MD

CONTACT

42109000; nestor.pistillo@hospitalelcruce.org

Lucia Duarte, BSN

CONTACT

42109000; lucymduarte1982@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UTIA

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: March 20, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)