Study of the Prevalence of Midline Replacements and the Reasons for These Replacements

NCT07394296 | Recruiting

• 1 other identifier: 2025-03-01
• Study Type: observational
• Target: 984
• Locations: 1 country
• Sites: 1

Brief Summary

Venous access management plays a key role in patient care and preserving their venous capital. The so-called "conventional" peripheral venous catheter is the most common venous access device, but it is associated with a high rate of complications, particularly in cases of prolonged use or poor venous capital. Recommendations, such as those from MAGIC or SF2H, advocate their use when the intended duration of use is 5 days or less. For longer periods or in cases of difficult access, so-called "central" devices such as PICC lines or central venous catheters are used, although they present specific risks such as CLASBI or deep vein thrombosis. In intermediate situations, the midline, a peripheral venous access device, is a relevant alternative, particularly for non-venotoxic intravenous treatments lasting more than 5 days. Although it is theoretically associated with fewer infections and complications than the PICCline, its complication rate and actual duration of use vary widely in the literature. The MAGIC recommendations suggest using them for periods of 14 days or less. The widespread use of midlines in healthcare facilities, and in particular the creation of vascular access units, has given rise to issues shared between centers, notably the replacement rate of these devices. The study therefore aims to determine the replacement and early removal rates for midlines, the circumstances in which they are replaced, and toassess the relevance of the 28-day limit in the choice of device, in order to improve practices and optimize the practitioner's initial decision.

Conditions

Veinous Access; Midline; Veinous Capital

Keywords

midline; midline placement; midline indication; patient care

Outcome Measures

Primary Outcomes (1)

• Evaluate the midline replacement rate regardless of the indication, in the various requesting centers

  The primary endpoint is the cumulative incidence rate of midline replacement over a censored period of 28 days. This period begins on the day of inclusion with the first midline placement, regardless of the indication. Competing events are removal without replacement, regardless of the cause (death, removal at the end of treatment, early removal before the end of treatment without replacement).

  within 28 days after the initial placement of the midline

Secondary Outcomes (5)

• Secondary objective 1: To evaluate the early removal rate among patients living with midlines within 28 days of placement.

  over a censored period of 28 days

• Secondary objective 2: Describe the reasons for early removal of midlines.

  Withdrawals are analyzed from the day of inclusion and over a censored period of 28 days

• Secondary objective 3: Describe the lifespan of midlines

  This duration includes the number of days between the day of inclusion and the day of device removal over a censored period of 28 days.

• Secondary objective 4: Describe the replacement rate of midlines among midlines still in place at different time

  Days 7, 14, 21 and 28

• Secondary objective 5: Compare the midline replacement rate between the initial indication of antibiotic therapy and the initial indication of insufficient venous capacity

  Replacements taken into account occur over a censored period of 28 days beginning on the day of inclusion

Eligibility Criteria

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

Study Population

Patients included in the study are those whose midline indication has been validated by the vascular access unit according to the hospital's organization. The expected duration of midline use should be 28 days or less.

You may qualify if:

• Patients over 18 years of age.
• Patients who have given their consent to participate in the study.
• Patients treated in a hospital unit authorized to insert midlines, or who have a midline inserted by a professional trained in this procedure, in accordance with the local organization of each center.
• First insertion for the treatment of a given event with an expected treatment duration of 28 days or less.
• Patients treated with a midline catheter at least 14 cm in length.

You may not qualify if:

• No coverage by the social security system
• Failure to insert the midline
• Patient under guardianship or conservatorship

Sponsors & Collaborators

• Centre Hospitalier de Valenciennes: lead

Study Sites (1)

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

RECRUITING

Central Study Contacts

Fanny DEFRANCQ, MD

CONTACT

0327149153; defrancq-f@ch-valenciennes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 33 Days
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: December 2, 2025
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): January 5, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

FR (1)