Vascular Access DeviceMIDREANCT03675711
Midline Catheter and Its Impact on Central Lines Removal in ICU
A study testing Midline and PVC in people with Vascular Access Device, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
The study will evaluate 2 strategies to remove central venous catheter (CVC): in one part, the insertion of a midline catheter and in the other part, the conventional insertion of peripheral venous catheter (PVC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Device
- What is being tested?
- Midline and PVC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2018to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- ≥18 years of age
- admitted to ICU since at least 48h
- with a perfusion CVC inserted
- requiring or having required invasive mechanical ventilation
- lack of formal indication to CVC maintenance (weaning of vasopressors and/or parenteral nutrition) since at least 24 hours
- indication to maintain a venous access
Who cannot join
- Lack of patient or next of kin consent
- Personnel for insertion of midline catheter not available
- Admission in ICU before study start
- Admission following a transfer from another ICU
- Patient with an implantable port or a peripherally inserted central catheter (PICC Line)
- Known intolerance to components of study Midline device
Show all 15Show fewer
- Past history of irradiation of insert area of midline catheter
- Past history of bilateral axillary lymph node dissection
- Pre-existing skin infection on upper limb
- Patient with a treatment-limitation decision
- Patient admitted after cardiac arrest with non-shockable rhythm
- Moribund
- Pregnancy, breastfeeding woman
- Patient under legal guardianship
- Patient hospitalized without consent and/or deprived of liberty by court's decision
Trial locations and contacts
1 site in 1 country.
About this study
The study will evaluate 2 strategies to remove central venous catheter (CVC): in one part, the insertion of a midline catheter and in the other part, the conventional insertion of peripheral venous catheter (PVC)
Read the detailed description
Patients will be randomised when the last indication for CVC has disappeared, which means parenteral nutrition or vasopressors administration.
They will be randomised either in the midline group or in the PVC group.
- In the midline group, a midline catheter will try to be inserted before the 48th hour after last indication for CVC disappeared.
- In the PVC group: a PVC will try to be inserted before the 48th hour after last indication for CVC disappeared.
If successful, CVC will then be removed. If not, a PVC will try to be inserted daily till success or worthlessness of a venous line or death.
The presence of a CVC will be assessed at the 96th hour after disappearance of last CVC indication.
- Conditions
- Vascular Access Device
- Being tested
- Midline, PVC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidlineDevice
Patient will receive a Midline catheter within 48h after disappearance of indication for CVC
PVCDevice
Also called Conventional catheterization
Patient will receive a standard PVC within 48h after disappearance of indication for CVC
| Study group | Role | What they receive |
|---|---|---|
| Midline Catheter | Active comparator | Pt. will receive midline catheters. Receives: Device: Midline |
| Standard Peripheral venous Catheter | Active comparator | Pt. will receive a standard Peripheral venous catheter Receives: Device: PVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patient with a successful Removal of CVC at the 96th hour after disappearance of last indication for CVC
A successful removal of CVC is defined as
- success of midline/PVC insertion at H96 and consequently CVC removal
- and no necessity for insertion of a new CVC within the 96 first hours
Measured: H96 : 96th hour after disappearance of last indication for CVC
Secondary outcomes (13)
Total number of puncture required for the insertion of a peripheral catheter
Measured: until 28 days after randomisation
Total number of peripheral catheter used
Measured: until 28 days after randomisation
Number of new CVC inserted
Measured: until 28 days after randomisation
Time consumption
Total time of catheterisation, (measured from the entrance in patient room, to the exit)
Measured: until 28 days after randomisation
Number of blood culture for research of catheter-related bloodstream infection (CRBSI)
Measured: until 28 days after randomisation
CVC dwell time
Time of central catheter duration (hours)
Measured: from disappearance of CVC indication to last CVC removal or 28 days after randomisation if still in place
Number of CVC colonized for per 1000 CVC /days
Measured: until 28 days after randomisation
Number of CVC-associated bacteremia
Measured: until 28 days after randomisation
Number of peripheral catheter-associated bacteremia
Measured: until 28 days after randomisation
ICU length of stay
Measured: Until discharge from ICU, an expected average of 12 days
Hospital length of stay
Hospital stay in medical and surgical unit (no follow-up and rehabilitation care unit or long stay)
Measured: Until discharge from hospital, an expected average of 20 days
ICU mortality
Measured: Until discharge from ICU, an expected average of 12 days
hospital mortality
mortality in medical and surgical unit (no SSR or long stay)
Measured: Until discharge from hospital, an expected average of 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start2 Nov 2018
- Primary completion3 Jan 2023
- Study completion13 Jan 2023
Why it stopped: recruitment problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access DeviceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- supportive care
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- angelina robert, Principal investigator, CHD vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675711
- Sponsor's protocol ID
- CHD 037-18
- Acronym
- MIDREA
- Status last verified
- Mar 2023
- First submitted
- 4 Sep 2018
- Last updated
- 22 Mar 2023
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midline Catheter and Its Impact on Central Lines Removal in ICU
- ClinicalTrials.gov ID
- NCT03675711
- Acronym / sponsor ID
- MIDREA / CHD 037-18
- Conditions
- Vascular Access Device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment problem
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 18 Sep 2018 (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.
The study will evaluate 2 strategies to remove central venous catheter (CVC): in one part, the insertion of a midline catheter and in the other part, the conventional insertion of peripheral venous catheter (PVC)
Detailed description
Patients will be randomised when the last indication for CVC has disappeared, which means parenteral nutrition or vasopressors administration.
They will be randomised either in the midline group or in the PVC group.
- In the midline group, a midline catheter will try to be inserted before the 48th hour after last indication for CVC disappeared.
- In the PVC group: a PVC will try to be inserted before the 48th hour after last indication for CVC disappeared.
If successful, CVC will then be removed. If not, a PVC will try to be inserted daily till success or worthlessness of a venous line or death.
The presence of a CVC will be assessed at the 96th hour after disappearance of last CVC indication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- supportive care
| Arm | Type | Receives |
|---|---|---|
| Midline Catheter | Active comparator | Device: MidlinePt. will receive midline catheters. |
| Standard Peripheral venous Catheter | Active comparator | Device: PVCPt. will receive a standard Peripheral venous catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years of age
- admitted to ICU since at least 48h
- with a perfusion CVC inserted
- requiring or having required invasive mechanical ventilation
- lack of formal indication to CVC maintenance (weaning of vasopressors and/or parenteral nutrition) since at least 24 hours
Key exclusion criteria (15 listed)
- Lack of patient or next of kin consent
- Personnel for insertion of midline catheter not available
- Admission in ICU before study start
- Admission following a transfer from another ICU
- Patient with an implantable port or a peripherally inserted central catheter (PICC Line)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidlinePatient will receive a Midline catheter within 48h after disappearance of indication for CVC | Device | Midline Catheter |
| PVCAlso: Conventional catheterizationPatient will receive a standard PVC within 48h after disappearance of indication for CVC | Device | Standard Peripheral venous Catheter |
Primary outcome
% of patient with a successful Removal of CVC at the 96th hour after disappearance of last indication for CVC
Time frame: H96 : 96th hour after disappearance of last indication for CVC
A successful removal of CVC is defined as * success of midline/PVC insertion at H96 and consequently CVC removal * and no necessity for insertion of a new CVC within the 96 first hours
13 secondary outcomes
Total number of puncture required for the insertion of a peripheral catheter
Time frame: until 28 days after randomisation
Total number of peripheral catheter used
Time frame: until 28 days after randomisation
Number of new CVC inserted
Time frame: until 28 days after randomisation
Time consumption
Time frame: until 28 days after randomisation
Number of blood culture for research of catheter-related bloodstream infection (CRBSI)
Time frame: until 28 days after randomisation
CVC dwell time
Time frame: from disappearance of CVC indication to last CVC removal or 28 days after randomisation if still in place
Number of CVC colonized for per 1000 CVC /days
Time frame: until 28 days after randomisation
Number of CVC-associated bacteremia
Time frame: until 28 days after randomisation
Number of peripheral catheter-associated bacteremia
Time frame: until 28 days after randomisation
ICU length of stay
Time frame: Until discharge from ICU, an expected average of 12 days
Hospital length of stay
Time frame: Until discharge from hospital, an expected average of 20 days
ICU mortality
Time frame: Until discharge from ICU, an expected average of 12 days
hospital mortality
Time frame: Until discharge from hospital, an expected average of 20 days
Results and safety
The study was stopped early (reason given: recruitment problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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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. This study is not recruiting at the moment.
angelina robert principal investigator
CHD vendee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midline and PVC in people with Vascular Access Device, run by Centre Hospitalier Departemental Vendee 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 Mar 2023. 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?
The study was stopped early (reason given: recruitment problem). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patient with a successful Removal of CVC at the 96th hour after disappearance of last indication for CVC (time frame: H96 : 96th hour after disappearance of last indication for CVC). 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 22 Mar 2023.