The Clinical Efficacy of Midline Catheters

NCT03457259 | Completed DMC

• 1 other identifier: midlineivauh18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.

Conditions

Intravenous Catheters

Keywords

Midline catheter, peripheral venous catheter, central venous catheter, complication rate

Outcome Measures

Primary Outcomes (1)

• Reducing the use of CVC and PVC

  The fraction of patients requiring either a CVC - including PICC line - or require ≥ 4PVC insertions during the current admittance to the hospital, including follow-up intravenous therapy.

  through study completion, an average of 7 month

Secondary Outcomes (23)

• Bloodsamples from catheter

  through study completion, an average of 7 month

• Problems with catheter bloodsampling

  through study completion, an average of 7 month

• Bloodsamples (conventional)

  through study completion, an average of 7 month

• Patient satisfaction

  through study completion, an average of 7 month

• Nurse satisfaction

  through study completion, an average of 7 month

Study Arms (2)

Midline

ACTIVE COMPARATOR

Pt. will receive midline catheters. The outcomes will be registered and some patients will be examined once weekly for thrombosis with ultrasound.

Device: Midline

Conventional

ACTIVE COMPARATOR

Pt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered.

Device: PVC and/or PICCline

Interventions

PVC and/or PICCline DEVICE

Pt. will receive PVC and/or PICCline

Also known as: Conventional catheterization

Conventional

Midline DEVICE

Pt. will receive midline

Also known as: Powerglide

Midline

Eligibility Criteria

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

You may qualify if:

• Admission to the Department of Infectious Disease or Department of Heart Disease.
• ≥18 years of age
• Expected requirement for iv. therapy \>5 days from the day of enrolment as evaluated by a specialist in infectious diseases.
• Mentally competency

You may not qualify if:

• Lack of patient consent
• Requirement for a CVC before study eligibility screening or anticipation of an absolute indication for CVC inserted within 24 hours of screening
• Personnel for insertion of midline catheter not available

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care East Section, Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.

  PMID: 36507736 DERIVED

Study Officials

• Emma Bundgaard, MS

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical student, Research student

Model Details: 60 patients in each group, with a total of 2 groups

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 7, 2018
• Study Start: February 12, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)