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

Acute Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05888376
• Other study ID #: BXU565389
• Status: Enrolling by invitation
• Start date: December 8, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

1. Duration of catheter use (survival)

2. Reason(s) for catheter removal

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• CKD
• ESRD

Intervention

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

Locations

Country	Name	City	State
Poland	Independent Public Health Care Unit, Leczna	Leczna
Poland	Independent Public Hospital No. 4, Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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