Safety and Efficacy of Midline and PICC

Central Venous Catheter Clinical Trial

— MidLine_PICC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502980
• Other study ID #: 7749
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: July 21, 2022

Study information

• Verified date: August 2021
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: July 21, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Venous Catheter
• Vascular Access Devices

Intervention

Device:
• Bard PowerPICC
PICC Insertion
• Bard PowerMidline catheter
Midline Insertion

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'université de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

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