Centre Hospitalier de Valenciennes
Valenciennes, 59300, France
Location status: Recruiting
Location contact
Jean-Baptiste VARANGUIEN DE VILLEPIN, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07394296
Study of the Prevalence of Midline Replacements and the Reasons for These Replacements
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- No coverage by the social security system
- Failure to insert the midline
- Patient under guardianship or conservatorship
Treatment and study plan
Primary outcomes
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Evaluate the midline replacement rate regardless of the indication, in the various requesting centers
Time frame: within 28 days after the initial placement of the midline
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).
Secondary outcomes
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Secondary objective 1: To evaluate the early removal rate among patients living with midlines within 28 days of placement.
Time frame: over a censored period of 28 days
Cumulative incidence rate of early removal of midlines placed on the day of inclusion over a censored period of 28 days. Competing events are death and removal due to end of treatment
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Secondary objective 2: Describe the reasons for early removal of midlines.
Time frame: Withdrawals are analyzed from the day of inclusion and over a censored period of 28 days
Midline removal rate for each of the following reasons:
- Extravasation/diffusion of the product
- Suspected midline infection
- Confirmed midline infection
- Accidental removal
- Catheter-induced deep vein thrombosis
- Catheter occlusion
- Inability to perform sampling
- Conversion to PICCline
- Duration exceeded
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Secondary objective 3: Describe the lifespan of midlines
Time frame: 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.
Midline lifespan. The event is the removal of the midline regardless of the cause: removal at the end of treatment, removal due to death, early removal (with or without reinsertion).
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Secondary objective 4: Describe the replacement rate of midlines among midlines still in place at different time
Time frame: Days 7, 14, 21 and 28
Cumulative incidence rate of midline recurrence with a benchmark at D7, D14, then D21, censored at D28
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Secondary objective 5: Compare the midline replacement rate between the initial indication of antibiotic therapy and the initial indication of insufficient venous capacity
Time frame: Replacements taken into account occur over a censored period of 28 days beginning on the day of inclusion
Cumulative incidence rate of midline removal for the initial indication of antibiotic therapy and midline removal rate for the initial indication of insufficient venous access. The midlines analyzed are those placed on the day of inclusion. Concurrent 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).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Centre Hospitalier de Valenciennes
Network
Registry information
Acronym: MIDRELAY
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 6, 2026
- Registry last updated
- Feb 10, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.