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

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)

Study Overview

• Status: Terminated
• Conditions: Vascular Access Device
• Intervention / Treatment: Device: Midline; Device: 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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Roche sur Yon, France, 85925
    • Centre Hospitalier Départemental Vendée

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Midline Catheter; Pt. will receive midline catheters.	Device: Midline; Patient will receive a Midline catheter within 48h after disappearance of indication for CVC
Active Comparator: Standard Peripheral venous Catheter; Pt. will receive a standard Peripheral venous catheter	Device: PVC; Patient will receive a standard PVC within 48h after disappearance of indication for CVC; Other Names: Conventional catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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	H96 : 96th hour after disappearance of last indication for CVC

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay		Until discharge from ICU, an expected average of 12 days
ICU mortality		Until discharge from ICU, an expected average of 12 days
Total number of puncture required for the insertion of a peripheral catheter		until 28 days after randomisation
Total number of peripheral catheter used		until 28 days after randomisation
Number of new CVC inserted		until 28 days after randomisation
Time consumption	Total time of catheterisation, (measured from the entrance in patient room, to the exit)	until 28 days after randomisation
Number of blood culture for research of catheter-related bloodstream infection (CRBSI)		until 28 days after randomisation
CVC dwell time	Time of central catheter duration (hours)	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		until 28 days after randomisation
Number of CVC-associated bacteremia		until 28 days after randomisation
Number of peripheral catheter-associated bacteremia		until 28 days after randomisation
Hospital length of stay	Hospital stay in medical and surgical unit (no follow-up and rehabilitation care unit or long stay)	Until discharge from hospital, an expected average of 20 days
hospital mortality	mortality in medical and surgical unit (no SSR or long stay)	Until discharge from hospital, an expected average of 20 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colonization of Midline at removal	swabbing will be performed at catheter removal and its tips will be also analyzed	until removal,an expected average of 10 days after insertion
Colonization of skin at insert point of Midline catheter	swabbing will be performed at every change of dressing	until 28 days after randomisation
Thrombosis at Midline removal	thrombosis will be checked by ultrasound-echography if midline is removed in ICU	until removal in ICU,an expected average of 10 days after insertion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CHD 037-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No