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

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ClinicalTrials.gov Identifier: NCT03675711
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

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)

Condition or disease Intervention/treatment Phase
Vascular Access Device Device: Midline Device: PVC Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: supportive care
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Midline Catheter and Its Impact on Central Lines Removal in ICU
Actual Study Start Date : November 2, 2018
Estimated Primary Completion Date : June 2, 2020
Estimated Study Completion Date : July 1, 2020

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 Name: Conventional catheterization




Primary Outcome Measures :
  1. % of patient with a successful Removal of CVC at the 96th hour after disappearance of last indication for CVC [ Time Frame: H96 : 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


Secondary Outcome Measures :
  1. Total number of puncture required for the insertion of a peripheral catheter [ Time Frame: until 28 days after randomisation ]
  2. Total number of peripheral catheter used [ Time Frame: until 28 days after randomisation ]
  3. Number of new CVC inserted [ Time Frame: until 28 days after randomisation ]
  4. Time consumption [ Time Frame: until 28 days after randomisation ]
    Total time of catheterisation, (measured from the entrance in patient room, to the exit)

  5. Number of blood culture for research of catheter-related bloodstream infection (CRBSI) [ Time Frame: until 28 days after randomisation ]
  6. CVC dwell time [ Time Frame: from disappearance of CVC indication to last CVC removal or 28 days after randomisation if still in place ]
    Time of central catheter duration (hours)

  7. Number of CVC colonized for per 1000 CVC /days [ Time Frame: until 28 days after randomisation ]
  8. Number of CVC-associated bacteremia [ Time Frame: until 28 days after randomisation ]
  9. Number of peripheral catheter-associated bacteremia [ Time Frame: until 28 days after randomisation ]
  10. ICU length of stay [ Time Frame: Until discharge from ICU, an expected average of 12 days ]
  11. Hospital length of stay [ Time Frame: Until discharge from hospital, an expected average of 20 days ]
    Hospital stay in medical and surgical unit (no follow-up and rehabilitation care unit or long stay)

  12. ICU mortality [ Time Frame: Until discharge from ICU, an expected average of 12 days ]
  13. hospital mortality [ Time Frame: Until discharge from hospital, an expected average of 20 days ]
    mortality in medical and surgical unit (no SSR or long stay)


Other Outcome Measures:
  1. Colonization of Midline at removal [ Time Frame: until removal,an expected average of 10 days after insertion ]
    swabbing will be performed at catheter removal and its tips will be also analyzed

  2. Colonization of skin at insert point of Midline catheter [ Time Frame: until 28 days after randomisation ]
    swabbing will be performed at every change of dressing

  3. Thrombosis at Midline removal [ Time Frame: until removal in ICU,an expected average of 10 days after insertion ]
    thrombosis will be checked by ultrasound-echography if midline is removed in ICU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675711


Contacts
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Contact: angelina robert 0251446212 angelina.robert@chd-vendee.fr
Contact: stéphanie martin 02511446483 stephanie.martin@chd-vendee.fr

Locations
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France
Centre Hospitalier Departemental Vendée Recruiting
La Roche sur Yon, France, 85925
Contact: angelina robert       angelina.robert@chd-vendee.fr   
Principal Investigator: angélina ROBERT         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Principal Investigator: angelina robert CHD vendee

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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT03675711     History of Changes
Other Study ID Numbers: CHD 037-18
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No