The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study

University of Aarhus1 site in 1 country120 target enrollmentFebruary 12, 2018

ConditionsIntravenous Catheters

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intravenous Catheters
Sponsor: University of Aarhus
Enrollment: 120
Locations: 1
Primary Endpoint: Reducing the use of CVC and PVC
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 12, 2018

End Date

July 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Aarhus

Responsible Party

Principal Investigator

Emma Bundgaard Nielsen

Medical student, Research student

University of Aarhus

Eligibility Criteria

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

Outcomes

Primary Outcomes

Reducing the use of CVC and PVC

Time Frame: through study completion, an average of 7 month

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.

Secondary Outcomes

Patient satisfaction(through study completion, an average of 7 month)
Rescue catherizations 2(through study completion, an average of 7 month)
Time consumption(through study completion, an average of 7 month)
Thrombosis 3(through study completion, an average of 7 month)
Catheter discontinuation(through study completion, an average of 7 month)
Problems with catheter bloodsampling(through study completion, an average of 7 month)
Nurse satisfaction(through study completion, an average of 7 month)
Bloodsamples from catheter(through study completion, an average of 7 month)
Catheter related infections(through study completion, an average of 7 month)
Thrombosis 4(through study completion, an average of 7 month)
Bloodsamples (conventional)(through study completion, an average of 7 month)
Fluid(through study completion, an average of 7 month)
Treatment type(through study completion, an average of 7 month)
Painscore(through study completion, an average of 7 month)
Thrombosis 1(through study completion, an average of 7 month)
Insertion complication 2(through study completion, an average of 7 month)
Rescue catherizations 1(through study completion, an average of 7 month)
Catheter dwelltime(through study completion, an average of 7 month)
Treatment amount(through study completion, an average of 7 month)
Thrombosis 2(through study completion, an average of 7 month)
Insertion complication 3(through study completion, an average of 7 month)
Neuropraxia(through study completion, an average of 7 month)
Insertion complication(through study completion, an average of 7 month)