Clinical trial NCT03457259: The Clinical Efficacy of Midline Catheters
Official title: The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Catheters
Keywords: Midline catheter, peripheral venous catheter, central venous catheter, complication rate
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 patients in each group, with a total of 2 groups
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Reducing the use of CVC and PVC
timeFrame: through study completion, an average of 7 month
Secondary outcomes:
measure: Bloodsamples from catheter
timeFrame: through study completion, an average of 7 month
measure: Problems with catheter bloodsampling
timeFrame: through study completion, an average of 7 month
measure: Bloodsamples (conventional)
timeFrame: through study completion, an average of 7 month
measure: Patient satisfaction
timeFrame: through study completion, an average of 7 month
measure: Nurse satisfaction
timeFrame: through study completion, an average of 7 month
measure: Painscore
timeFrame: through study completion, an average of 7 month
measure: Rescue catherizations 1
timeFrame: through study completion, an average of 7 month
measure: Rescue catherizations 2
timeFrame: through study completion, an average of 7 month
measure: Time consumption
timeFrame: through study completion, an average of 7 month
measure: Catheter dwelltime
timeFrame: through study completion, an average of 7 month
measure: Fluid
timeFrame: through study completion, an average of 7 month
measure: Treatment type
timeFrame: through study completion, an average of 7 month
measure: Treatment amount
timeFrame: through study completion, an average of 7 month
measure: Catheter related infections
timeFrame: through study completion, an average of 7 month
measure: Thrombosis 1
timeFrame: through study completion, an average of 7 month
measure: Thrombosis 2
timeFrame: through study completion, an average of 7 month
measure: Thrombosis 3
timeFrame: through study completion, an average of 7 month
measure: Thrombosis 4
timeFrame: through study completion, an average of 7 month
measure: Catheter discontinuation
timeFrame: through study completion, an average of 7 month
measure: Insertion complication
timeFrame: through study completion, an average of 7 month
measure: Insertion complication 2
timeFrame: through study completion, an average of 7 month
measure: Insertion complication 3
timeFrame: through study completion, an average of 7 month
measure: Neuropraxia
timeFrame: through study completion, an average of 7 month
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Anaesthesiology and Intensive Care East Section, Aarhus University
Study officials:
affiliation: Aarhus University Hospital
name: Emma Bundgaard, MS
role: PRINCIPAL_INVESTIGATOR
References: