A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
Study Details
Study Description
Brief Summary
The goal of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter in patients with acute kidney injury, acute renal failure, or chronic kidney disease.
The main questions to answer are:
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Duration of catheter use (survival)
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Reason(s) for catheter removal
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The objective of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter related to the duration of use (catheter survival) throughout its lifetime.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Consecutive CKD including ESRD treatments Consecutive retrospective treatments across all sites with a diagnosis of CKD, including ESRD |
Device: Vascular access catheter to support dialysis or CRRT
A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT
|
| Consecutive treatments with minimum hospital stay of 20 days Consecutive retrospective treatments across all sites with a minimum hospital stay of days (excluding cases previously identified; may be acute or chronic disease) |
Device: Vascular access catheter to support dialysis or CRRT
A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT
|
| Consecutive acute/chronic kidney disease treatments Consecutive retrospective treatments across all sites with acute or chronic disease (excluding cases previously identified) |
Device: Vascular access catheter to support dialysis or CRRT
A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT
|
Outcome Measures
Primary Outcome Measures
- Catheter Survival [From date of catheter insertion until the date of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks]
Confirm catheter lifetime related to GamCath HighFlow Dolphin Protect Catheter duration of use to support PMCF ongoing performance data
- Reason(s) for Catheter Removal [Within 72 hours of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks]
Collect additional real-world use data describing the reason(s) for GamCath HighFlow Dolphin Protect Catheter removal to support PMCF ongoing product safety performance
Secondary Outcome Measures
- Adverse Events [From date of catheter insertion until the date of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks]
Collect real-world use data describing adverse events potentially related to the study catheter or catheter insertion/removal procedures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients ≥ 18 years of age at the time of catheter insertion.
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Patients diagnosed with AKI, ARF, and/or CKD (including end-stage renal disease [ESRD]).
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Patients who required vascular access to perform extracorporeal blood purification using GamCath HighFlow Dolphin Protect Catheter inserted by a physician in the subclavian, jugular, or femoral veins.
Exclusion Criteria:
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Patients who required the GamCath HighFlow Dolphin Protect Catheter for any indication other than extracorporeal blood purification.
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Patients who had a local infection at the vascular access site prior to catheter insertion.
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Patients who required surgical intervention (e.g., cutdown procedure) for GamCath HighFlow Dolphin Protect Catheter placement.
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Patients who had a prior catheter in place at the same vascular access site (i.e., R/L jugular vein, R/L femoral vein, R/L subclavian vein) within the last 7 days.
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Patients who do not have complete patient records to support the primary endpoint analyses.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Independent Public Hospital No. 4, Lublin | Lublin | Poland | 20-954 | |
| 2 | Independent Public Health Care Unit, Łęczna | Łęczna | Poland | 21-010 |
Sponsors and Collaborators
- Baxter Healthcare Corporation
Investigators
- Principal Investigator: Wojciech Dąbrowski, Prof MD PhD, Independent Public Clinical Hospital No. 4, Lublin
- Principal Investigator: Marek Winiarz, MD, Independent Public Health Care Unit, Łęczna
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BXU565389