The Clinical Efficacy of Midline Catheters

April 3, 2020 updated by: Emma Bundgaard Nielsen, University of Aarhus

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Anaesthesiology and Intensive Care East Section, Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Midline
Pt. will receive midline catheters. The outcomes will be registered and some patients will be examined once weekly for thrombosis with ultrasound.
Device: Midline
Pt. will receive midline
Other Names:
  • Powerglide
Active Comparator: Conventional
Pt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered.
Device: PVC and/or PICCline
Pt. will receive PVC and/or PICCline
Other Names:
  • Conventional catheterization

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 7 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bloodsamples from catheter
Time Frame: through study completion, an average of 7 month
Registration of number of blood samples taken from the midline catheter
through study completion, an average of 7 month
Problems with catheter bloodsampling
Time Frame: through study completion, an average of 7 month
Registration of aspiration problems during bloodsampling in midline catheters
through study completion, an average of 7 month
Bloodsamples (conventional)
Time Frame: through study completion, an average of 7 month
Registration of number of blood samples taken from conventional blood samples in both groups
through study completion, an average of 7 month
Patient satisfaction
Time Frame: through study completion, an average of 7 month
Patient satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied
through study completion, an average of 7 month
Nurse satisfaction
Time Frame: through study completion, an average of 7 month
Nurse satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied
through study completion, an average of 7 month
Painscore
Time Frame: through study completion, an average of 7 month
Accumulated NRS pain score for all IV catheter insertions. 0 is no pain and 10 is worst imaginable pain
through study completion, an average of 7 month
Rescue catherizations 1
Time Frame: through study completion, an average of 7 month
Rescue PVC's inserted (midline group) (no)
through study completion, an average of 7 month
Rescue catherizations 2
Time Frame: through study completion, an average of 7 month
Rescue central venous catheters including PICC line catheters inserted (no)
through study completion, an average of 7 month
Time consumption
Time Frame: through study completion, an average of 7 month
Total time of cauterization, (measured from the entrance in patient room, to the exit)
through study completion, an average of 7 month
Catheter dwelltime
Time Frame: through study completion, an average of 7 month
Time of catheter duration (hours)
through study completion, an average of 7 month
Fluid
Time Frame: through study completion, an average of 7 month
Accumulated fluids infused (L)
through study completion, an average of 7 month
Treatment type
Time Frame: through study completion, an average of 7 month
Type of medicine infused (all types)
through study completion, an average of 7 month
Treatment amount
Time Frame: through study completion, an average of 7 month
Amount of medicine infused (L)
through study completion, an average of 7 month
Catheter related infections
Time Frame: through study completion, an average of 7 month
Catheters removed due to suspected catheter-related infection (no)
through study completion, an average of 7 month
Thrombosis 1
Time Frame: through study completion, an average of 7 month
Thrombi visible at the catheter tip (no)
through study completion, an average of 7 month
Thrombosis 2
Time Frame: through study completion, an average of 7 month
Deep venous thrombosis of the ipsilateral arm (no)
through study completion, an average of 7 month
Thrombosis 3
Time Frame: through study completion, an average of 7 month
Superficial venous thrombosis of the ipsilateral arm (midline group) (no)
through study completion, an average of 7 month
Thrombosis 4
Time Frame: through study completion, an average of 7 month
Patients starting anti-thrombotic medicine due to thrombi generated by an IV catheter (no)
through study completion, an average of 7 month
Catheter discontinuation
Time Frame: through study completion, an average of 7 month
Reasons for replacing catheters (all types)
through study completion, an average of 7 month
Insertion complication
Time Frame: through study completion, an average of 7 month
Arterial punctures during catheter insertions (no)
through study completion, an average of 7 month
Insertion complication 2
Time Frame: through study completion, an average of 7 month
haematomas during catheter insertions (no)
through study completion, an average of 7 month
Insertion complication 3
Time Frame: through study completion, an average of 7 month
Misplaced catheters (no)
through study completion, an average of 7 month
Neuropraxia
Time Frame: through study completion, an average of 7 month
Post-procedure median nerve palsy/neuropraxia (midline group) (no)
through study completion, an average of 7 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emma Bundgaard, MS, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • midlineivauh18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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