Midline Catheter and Its Impact on Central Lines Removal in ICU

NCT03675711 | Terminated

• 1 other identifier: CHD 037-18
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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)

Conditions

Vascular Access Device

Outcome Measures

Primary Outcomes (1)

• % 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 Outcomes (13)

• 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

  until 28 days after randomisation

• Number of blood culture for research of catheter-related bloodstream infection (CRBSI)

  until 28 days after randomisation

Other Outcomes (3)

• Colonization of Midline at removal

  until removal,an expected average of 10 days after insertion

• Colonization of skin at insert point of Midline catheter

  until 28 days after randomisation

• Thrombosis at Midline removal

  until removal in ICU,an expected average of 10 days after insertion

Study Arms (2)

Midline Catheter

ACTIVE COMPARATOR

Pt. will receive midline catheters.

Device: Midline

Standard Peripheral venous Catheter

ACTIVE COMPARATOR

Pt. will receive a standard Peripheral venous catheter

Device: PVC

Interventions

Midline DEVICE

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

Midline Catheter

PVC DEVICE

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

Also known as: Conventional catheterization

Standard Peripheral venous Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

Centre Hospitalier Departemental Vendée

La Roche-sur-Yon, 85925, France

Location

Study Officials

• angelina robert

  CHD vendee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: supportive care

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 18, 2018
• Study Start: November 2, 2018
• Primary Completion: January 3, 2023
• Study Completion: January 13, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

FR (1)