Central Venous Catheter Clinical Trial
— MidLine_PICCOfficial title:
Safety and Efficacy of Midline and Peripherally Inserted Central Catheter for Intravenous Therapy: a Randomized Controlled Trial
NCT number | NCT03502980 |
Other study ID # | 7749 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | July 21, 2022 |
Verified date | August 2021 |
Source | Centre hospitalier de l'Université de Montréal (CHUM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier de l'université de Montréal | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
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 |
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