Midline Catheter and Its Impact on Central Lines Removal in ICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-02

Study Completion Date

2023-01-13

Brief Summary

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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)

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Detailed Description

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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

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Vascular Access Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

supportive care

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Midline Catheter

Pt. will receive midline catheters.

Group Type ACTIVE_COMPARATOR

Midline

Intervention Type DEVICE

Patient will receive a Midline catheter within 48h after disappearance of indication for CVC

Standard Peripheral venous Catheter

Pt. will receive a standard Peripheral venous catheter

Group Type ACTIVE_COMPARATOR

PVC

Intervention Type DEVICE

Patient will receive a standard PVC within 48h after disappearance of indication for CVC

Interventions

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Midline

Patient will receive a Midline catheter within 48h after disappearance of indication for CVC

Intervention Type DEVICE

PVC

Patient will receive a standard PVC within 48h after disappearance of indication for CVC

Intervention Type DEVICE

Other Intervention Names

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Conventional catheterization

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No