Clinical trial NCT03675711: Midline Catheter and Its Impact on Central Lines Removal in ICU
Official title: Midline Catheter and Its Impact on Central Lines Removal in ICU
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Access Device
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: supportive care
Primary purpose: SUPPORTIVE_CARE

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

* ≥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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: % of patient with a successful Removal of CVC at the 96th hour after disappearance of last indication for CVC
timeFrame: H96 : 96th hour after disappearance of last indication for CVC
Secondary outcomes:
measure: Total number of puncture required for the insertion of a peripheral catheter
timeFrame: until 28 days after randomisation
measure: Total number of peripheral catheter used
timeFrame: until 28 days after randomisation
measure: Number of new CVC inserted
timeFrame: until 28 days after randomisation
measure: Time consumption
timeFrame: until 28 days after randomisation
measure: Number of blood culture for research of catheter-related bloodstream infection (CRBSI)
timeFrame: until 28 days after randomisation
measure: CVC dwell time
timeFrame: from disappearance of CVC indication to last CVC removal or 28 days after randomisation if still in place
measure: Number of CVC colonized for per 1000 CVC /days
timeFrame: until 28 days after randomisation
measure: Number of CVC-associated bacteremia
timeFrame: until 28 days after randomisation
measure: Number of peripheral catheter-associated bacteremia
timeFrame: until 28 days after randomisation
measure: ICU length of stay
timeFrame: Until discharge from ICU, an expected average of 12 days
measure: Hospital length of stay
timeFrame: Until discharge from hospital, an expected average of 20 days
measure: ICU mortality
timeFrame: Until discharge from ICU, an expected average of 12 days
measure: hospital mortality
timeFrame: Until discharge from hospital, an expected average of 20 days
Other outcomes:
measure: Colonization of Midline at removal
timeFrame: until removal,an expected average of 10 days after insertion
measure: Colonization of skin at insert point of Midline catheter
timeFrame: until 28 days after randomisation
measure: Thrombosis at Midline removal
timeFrame: until removal in ICU,an expected average of 10 days after insertion
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental Vendée
Study officials:
affiliation: CHD vendee
name: angelina robert
role: PRINCIPAL_INVESTIGATOR
References: