Veinous AccessMIDRELAYNCT07394296
Study of the Prevalence of Midline Replacements and the Reasons for These Replacements
An observational study of Veinous Access and Midline, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Veinous Access, Midline, Veinous Capital
- How many people
- 984 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2025to 5 Jan 2027
- How long will I take part?
- 33 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- No coverage by the social security system
- Failure to insert the midline
- Patient under guardianship or conservatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Valenciennes
Valenciennes, 59300
Jean-Baptiste VARANGUIEN DE VILLEPIN, MD
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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
Measured: over a censored period of 28 days
Secondary objective 2: Describe the reasons for early removal of midlines.
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
Measured: Withdrawals are analyzed from the day of inclusion and over a censored period of 28 days
Secondary objective 3: Describe the lifespan of midlines
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).
Measured: 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
Cumulative incidence rate of midline recurrence with a benchmark at D7, D14, then D21, censored at D28
Measured: 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
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).
Measured: Replacements taken into account occur over a censored period of 28 days beginning on the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start2 Dec 2025
- Primary completion5 Jan 2027 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Veinous AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 984 participants (estimated)
- Target duration
- 33 Days
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394296
- Sponsor's protocol ID
- 2025-03-01
- Acronym
- MIDRELAY
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Midline Replacements and the Reasons for These Replacements
- ClinicalTrials.gov ID
- NCT07394296
- Acronym / sponsor ID
- MIDRELAY / 2025-03-01
- Conditions
- Veinous Access, Midline, Veinous Capital
- Keywords
- midline, midline placement, midline indication, patient care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 984 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 33 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- No coverage by the social security system
- Failure to insert the midline
- Patient under guardianship or conservatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
5 secondary outcomes
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
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
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Veinous Access and Midline, run by Centre Hospitalier de Valenciennes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanny DEFRANCQ, MD (0327149153, defrancq-f@ch-valenciennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.