Safety and Efficacy of Midline and PICC (MidLine_PICC)

July 22, 2022 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Safety and Efficacy of Midline and Peripherally Inserted Central Catheter for Intravenous Therapy: a Randomized Controlled Trial

The purpose of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.

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.

Detailed Description

Vascular access devices (VADs), including peripherally inserted central venous catheters (PICCs) remain a cornerstone for the delivery of necessary intravenous therapy. PICCs are being selected for venous access more frequently today than ever before.

The advantage of PICC is that it can be used for all intravenous therapy. However, PICC requires the use of fluoroscopy or other type of guidance which add to the cost and time required to insert the catheter. Midline, on the other hand, can be inserted under ultrasound guidance, takes less time to be inserted and cost less than PICC insertion.

Despite lower cost and better accessibility of midline in comparison with PICC for non-vesicant intravenous therapy, there is very little evidence in the literature to suggest that one type of venous access is better than the other.

The primary objective of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.

Results of this trial will allow improving a quality of evidence for using midline instead of PICC for specified indications. If Midline are non-inferior for some indications, they would represent a more accessible and less expensive alternative than PICC insertion.

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.
293

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Université de Montréal

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Required intra venous therapy
  • Expected duration of the venous access: > 6 days and < 30days

Exclusion Criteria:

  • Patient has a contraindication to insertion of either a Midline or a PICC relative to the therapy
  • Patient from other hospitals who come to the CHUM only for the installation of a central line
  • Decreased cognitive ability to care for device at home
  • Preexisting bacteremia (ie, existing positive blood cultures that had not been repeated with negative results)
  • Preexisting venous thrombosis or known hypercoagulable states (such as protein C or S deficiency, antithrombin deficiency, lupus anticoagulant)
  • Venous access with multiple lumens required
  • Patients not able to give informed consent
  • Prior participation to this study
  • Patient is enrolled in another investigational study
  • Patients hospitalized in the intensive care unit
  • Patients who are difficult to puncture and require multiple blood samples

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: Supportive Care
  • 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: Peripherally inserted central venous catheters
Bard PowerPICC
Device: Bard PowerPICC
PICC Insertion
Active Comparator: Midline
Bard PowerMidline catheter
Device: Bard PowerMidline catheter
Midline Insertion

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
% of patients without VAD-related adverse event requiring medical intervention
Time Frame: Until 1 week after VAD retrieval
Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death
Until 1 week after VAD retrieval
% of patients whose intended or additional I.V treatments could be completed with the VAD without VAD complications, dysfunctions or limitations (ex: need for central access or for additional peripheral or central lumens/catheters)
Time Frame: Until 1 week after VAD retrieval
Until 1 week after VAD retrieval

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
% of patients who experience VAD-related adverse events requiring medical intervention
Time Frame: Until 1 week after VAD retrieval
Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death
Until 1 week after VAD retrieval
Number of VAD-related adverse events requiring medical intervention per 1000 catheter/days
Time Frame: Until 1 week after VAD retrieval
Until 1 week after VAD retrieval
Time to first VAD-related adverse events
Time Frame: Until 1 week after VAD retrieval
Until 1 week after VAD retrieval
Duration VAD intervention (Midline or PICC)
Time Frame: Index procedure
Index procedure
Number of additional interventions to insert the VAD
Time Frame: Index procedure
Index procedure
% of patients who required another VAD to complete the intended or additional iv treatments, either because of VAD complications, dysfunctions or limitations
Time Frame: Until 1 week after VAD retrieval
Until 1 week after VAD retrieval
% of patient without failed blood sampling attempts through the VAD
Time Frame: Until 1 week after VAD retrieval
Until 1 week after VAD retrieval
% of patients for whom the end of treatment was the reason for VAD retrieval
Time Frame: Until 1 week after VAD retrieval
Until 1 week after VAD retrieval

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.
Centre hospitalier de l'Université de Montréal (CHUM)

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: Éric Therasse, MD, Centre hospitalier de l'Université de Montréal (CHUM)

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.
July 1, 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 21, 2022

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 21, 2022

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).
April 9, 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.
April 18, 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.
April 19, 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.
July 25, 2022

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.
July 22, 2022

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.
August 1, 2021

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.
  • 7749

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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