Clinical trial NCT03502980: Safety and Efficacy of Midline and PICC
Official title: Safety and Efficacy of Midline and Peripherally Inserted Central Catheter for Intravenous Therapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Devices
Central Venous Catheter
Keywords: Peripherally Inserted Central Catheter Line Insertion
Catheterization, Peripheral Venous
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: % of patients without VAD-related adverse event requiring medical intervention
timeFrame: Until 1 week after VAD retrieval
measure: % 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)
timeFrame: Until 1 week after VAD retrieval
Secondary outcomes:
measure: % of patients who experience VAD-related adverse events requiring medical intervention
timeFrame: Until 1 week after VAD retrieval
measure: Number of VAD-related adverse events requiring medical intervention per 1000 catheter/days
timeFrame: Until 1 week after VAD retrieval
measure: Time to first VAD-related adverse events
timeFrame: Until 1 week after VAD retrieval
measure: Duration VAD intervention (Midline or PICC)
timeFrame: Index procedure
measure: Number of additional interventions to insert the VAD
timeFrame: Index procedure
measure: % of patients who required another VAD to complete the intended or additional iv treatments, either because of VAD complications, dysfunctions or limitations
timeFrame: Until 1 week after VAD retrieval
measure: % of patient without failed blood sampling attempts through the VAD
timeFrame: Until 1 week after VAD retrieval
measure: % of patients for whom the end of treatment was the reason for VAD retrieval
timeFrame: Until 1 week after VAD retrieval
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre hospitalier de l'université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Éric Thérasse, MD
role: PRINCIPAL_INVESTIGATOR
References: