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Midline Catheter and Its Impact on Central Lines Removal in ICU (MIDREA)

C

Centre Hospitalier Departemental Vendee

Status

Terminated

Conditions

Vascular Access Device

Treatments

Device: PVC
Device: Midline

Study type

Interventional

Funder types

Other

Identifiers

NCT03675711
CHD 037-18

Details and patient eligibility

About

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)

Full 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.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

83 participants in 2 patient groups

Midline Catheter
Active Comparator group
Description:
Pt. will receive midline catheters.
Treatment:
Device: Midline
Standard Peripheral venous Catheter
Active Comparator group
Description:
Pt. will receive a standard Peripheral venous catheter
Treatment:
Device: PVC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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