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出境医 / 临床实验 / BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden (IMPROWE)
BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden (IMPROWE)
Study Description
Brief Summary:
Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC.
(CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vascular Access Complication Catheter-Related Infections Catheter Thrombosis Catheter Blockage Catheter Complications Catheter Site Discomfort Catheter Bacteraemia | Device: BIP CVC Device: Standard CVC | Not Applicable |
Detailed Description:
Catheter related complications include CRBSI, CRI, Local CVC infection, need to exchange of CVC due to suspected CRI/CRBSI or thrombosis, stop / slower flow in any CVC lumen, local thrombosis, device malfunctions / technical catheter problems, device related adverse events.
(CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection)
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 19 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Pilot, randomized, open label, controlled trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol |
| Actual Study Start Date : | April 11, 2019 |
| Actual Primary Completion Date : | December 18, 2019 |
| Actual Study Completion Date : | December 18, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: BIP CVC
Polyurethane CVC with noble metal coating
|
Device: BIP CVC
Central venous access with noble metal coated CVC
Other Name: Noble metal coated CVC
|
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Active Comparator: Standard CVC
Standard CVC made of polyurethane
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Device: Standard CVC
Central venous access with standard uncoated CVC
Other Name: Uncoated CVC
|
Outcome Measures
Primary Outcome Measures :
- Number of patients with catheter related complications [ Time Frame: From CVC insertion until CVC withdrawal ]Patients having any complication specified as secondary endpoints
Secondary Outcome Measures :
- Number of patients with CRBSI [ Time Frame: From CVC insertion until CVC withdrawal ]CRBSI - Catheter Related Blood Stream Infections
- Number of patients with CRI [ Time Frame: From CVC insertion until CVC withdrawal ]CRI - Catheter Related Infections
- Number of patients with local CVC infections [ Time Frame: From CVC insertion until CVC withdrawal ]Skin infection at the insertion site
- Number of CVC exchanges per patient due to suspected infection or thrombosis [ Time Frame: From CVC insertion until CVC withdrawal ]Reported as incidence
- Number of patients with stop or slower flow in any CVC lumen [ Time Frame: From CVC insertion until CVC withdrawal ]Stop or slower flow or need of high pressure during blood sample withdrawal and/or injection of solution
- Number of patients with local thrombosis [ Time Frame: From CVC insertion until CVC withdrawal ]Local thrombosis - thrombosis in the insertion vein
- Number of patients with device malfunctions [ Time Frame: From CVC insertion until CVC withdrawal ]Any device malfunction or technical problems during insertion, withdrawal or use
- Number of patients with antibiotics and antithrombotics drug use [ Time Frame: From CVC insertion until CVC withdrawal ]including the reason of use and dose / number of days
- Number of patients with adverse events [ Time Frame: From CVC insertion until CVC withdrawal ]including casuality assessment to the CVC use; both serious and non-serious
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients admitted to the Access Center at Danderyd who need an elective CVC (surgery, infection, nutrition, medication…)
- Fully recognize and understand patient information
- Signed informed consent
Exclusion Criteria:
- If CVC present prior to inclusion in the study and no intention to change the present CVC over guidewire
- Age < 18 years
- Pregnant women
- Known allergy to gold, silver and palladium
- Participation in other clinical studies which may interfere with this study as judged by the Investigator
Contacts and Locations
Locations
| Sweden | |
| Danderyd Sjukhus | |
| Stockholm, Sweden, 18288 | |
Sponsors and Collaborators
Bactiguard AB
Danderyd Hospital
Investigators
| Principal Investigator: | Jan Jakobsson, Prof | Danderyd Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 4, 2019 | ||||
| First Posted Date ICMJE | June 6, 2019 | ||||
| Last Update Posted Date | January 22, 2021 | ||||
| Actual Study Start Date ICMJE | April 11, 2019 | ||||
| Actual Primary Completion Date | December 18, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of patients with catheter related complications [ Time Frame: From CVC insertion until CVC withdrawal ] Patients having any complication specified as secondary endpoints
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| Original Primary Outcome Measures ICMJE |
Catheter related complications [ Time Frame: From CVC insertion until CVC withdrawal ] Sum of all complications specified as secondary endpoints
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden | ||||
| Official Title ICMJE | Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol | ||||
| Brief Summary |
Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC. (CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection) |
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| Detailed Description |
Catheter related complications include CRBSI, CRI, Local CVC infection, need to exchange of CVC due to suspected CRI/CRBSI or thrombosis, stop / slower flow in any CVC lumen, local thrombosis, device malfunctions / technical catheter problems, device related adverse events. (CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection) |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Pilot, randomized, open label, controlled trial Masking: None (Open Label)Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Actual Enrollment ICMJE |
19 | ||||
| Original Estimated Enrollment ICMJE |
150 | ||||
| Actual Study Completion Date ICMJE | December 18, 2019 | ||||
| Actual Primary Completion Date | December 18, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Sweden | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03976557 | ||||
| Other Study ID Numbers ICMJE | PL-13732 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Bactiguard AB | ||||
| Study Sponsor ICMJE | Bactiguard AB | ||||
| Collaborators ICMJE | Danderyd Hospital | ||||
| Investigators ICMJE |
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| PRS Account | Bactiguard AB | ||||
| Verification Date | January 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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