A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter

Study Overview
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Brief Summary
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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: Duration of catheter use (survival) Reason(s) for catheter removal

Detailed Description
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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.

Official Title
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A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter

Conditions
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AKI - Acute Kidney Injury, Acute Renal Failure, CKD, ESRD

Intervention / Treatment
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* Device: Vascular access catheter to support dialysis or CRRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age at the time of catheter insertion. Patients diagnosed with AKI, ARF, and/or CKD (including end-stage renal disease [ESRD]). 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: Patients who required the GamCath HighFlow Dolphin Protect Catheter for any indication other than extracorporeal blood purification. Patients who had a local infection at the vascular access site prior to catheter insertion. Patients who required surgical intervention (e.g., cutdown procedure) for GamCath HighFlow Dolphin Protect Catheter placement. 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. Patients who do not have complete patient records to support the primary endpoint analyses.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consecutive CKD including ESRD treatments<br>Consecutive retrospective treatments across all sites with a diagnosis of CKD, including ESRD | Device: Vascular access catheter to support dialysis or CRRT<br>* A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT<br>|
| Consecutive treatments with minimum hospital stay of 20 days<br>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<br>* A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT<br>|
| Consecutive acute/chronic kidney disease treatments<br>Consecutive retrospective treatments across all sites with acute or chronic disease (excluding cases previously identified) | Device: Vascular access catheter to support dialysis or CRRT<br>* A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter Survival | Confirm catheter lifetime related to GamCath HighFlow Dolphin Protect Catheter duration of use to support PMCF ongoing performance data | 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 | 
| Reason(s) for Catheter Removal | Collect additional real-world use data describing the reason(s) for GamCath HighFlow Dolphin Protect Catheter removal to support PMCF ongoing product safety performance | Within 72 hours of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Collect real-world use data describing adverse events potentially related to the study catheter or catheter insertion/removal procedures | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extracorporeal blood purification, continuous renal replacement therapy