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

Vantive Health LLC

Status: Completed

Conditions: ESRD; CKD; AKI - Acute Kidney Injury; Acute Renal Failure

Treatments: Device: Vascular access catheter to support dialysis or CRRT

Study type: Observational

Funder types: Industry

Identifiers

NCT05888376

BXU565389

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

76 participants in 3 patient groups

Consecutive CKD including ESRD treatments

Description:

Consecutive retrospective treatments across all sites with a diagnosis of CKD, including ESRD

Treatment:

Device: Vascular access catheter to support dialysis or CRRT

Consecutive treatments with minimum hospital stay of 20 days

Description:

Consecutive retrospective treatments across all sites with a minimum hospital stay of days (excluding cases previously identified; may be acute or chronic disease)

Treatment:

Device: Vascular access catheter to support dialysis or CRRT

Consecutive acute/chronic kidney disease treatments

Description:

Consecutive retrospective treatments across all sites with acute or chronic disease (excluding cases previously identified)

Treatment:

Device: Vascular access catheter to support dialysis or CRRT