Midline Catheter and Its Impact on Central Lines Removal in ICU

Vascular Access Device Clinical Trial

— MIDREA  

Official title:

Midline Catheter and Its Impact on Central Lines Removal in ICU

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03675711
• Other study ID #: CHD 037-18
• Status: Terminated
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: January 13, 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: January 13, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Access Device

Intervention

Device:
• Midline
Patient will receive a Midline catheter within 48h after disappearance of indication for CVC
• PVC
Patient will receive a standard PVC within 48h after disappearance of indication for CVC

Locations

Country	Name	City	State
France	Centre Hospitalier Departemental Vendée	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Colonization of skin at insert point of Midline catheter	swabbing will be performed at every change of dressing	until 28 days after randomisation
Other	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
Primary	% 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	Total number of puncture required for the insertion of a peripheral catheter		until 28 days after randomisation
Secondary	Total number of peripheral catheter used		until 28 days after randomisation
Secondary	Number of new CVC inserted		until 28 days after randomisation
Secondary	Time consumption	Total time of catheterisation, (measured from the entrance in patient room, to the exit)	until 28 days after randomisation
Secondary	Number of blood culture for research of catheter-related bloodstream infection (CRBSI)		until 28 days after randomisation
Secondary	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
Secondary	Number of CVC colonized for per 1000 CVC /days		until 28 days after randomisation
Secondary	Number of CVC-associated bacteremia		until 28 days after randomisation
Secondary	Number of peripheral catheter-associated bacteremia		until 28 days after randomisation
Secondary	ICU length of stay		Until discharge from ICU, an expected average of 12 days
Secondary	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
Secondary	ICU mortality		Until discharge from ICU, an expected average of 12 days
Secondary	hospital mortality	mortality in medical and surgical unit (no SSR or long stay)	Until discharge from hospital, an expected average of 20 days