The Clinical Efficacy of Midline Catheters

NCT ID: NCT03457259

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2019-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intravenous Catheters

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

60 patients in each group, with a total of 2 groups
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Midline

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

Group Type ACTIVE_COMPARATOR

Midline

Intervention Type DEVICE

Pt. will receive midline

Conventional

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

Group Type ACTIVE_COMPARATOR

PVC and/or PICCline

Intervention Type DEVICE

Pt. will receive PVC and/or PICCline

Interventions

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PVC and/or PICCline

Pt. will receive PVC and/or PICCline

Intervention Type DEVICE

Midline

Pt. will receive midline

Intervention Type DEVICE

Other Intervention Names

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Conventional catheterization Powerglide

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Emma Bundgaard Nielsen

Medical student, Research student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emma Bundgaard, MS

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Department of Anaesthesiology and Intensive Care East Section, Aarhus University

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36507736 (View on PubMed)

Other Identifiers

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midlineivauh18

Identifier Type: -

Identifier Source: org_study_id

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