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

NCT05888376 | Completed FDA Device

• 1 other identifier: BXU565389
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 2

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:

1. 1.Duration of catheter use (survival)
2. 2.Reason(s) for catheter removal

Conditions

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

Keywords

extracorporeal blood purification; continuous renal replacement therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (3)

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

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

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

Interventions

Vascular access catheter to support dialysis or CRRT DEVICE

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 CKD including ESRD treatments; Consecutive acute/chronic kidney disease treatments; Consecutive treatments with minimum hospital stay of 20 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data will be collected from records of adult patients in whom the GamCath HighFlow Dolphin Protect Catheter was inserted as a vascular access to perform extracorporeal blood purification from 2018 to most recent.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (2)

Independent Public Hospital No. 4, Lublin

Lublin, 20-954, Poland

Location

Independent Public Health Care Unit, Łęczna

Łęczna, 21-010, Poland

Location

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wojciech Dąbrowski, Prof MD PhD

  Independent Public Clinical Hospital No. 4, Lublin

  PRINCIPAL INVESTIGATOR

• Marek Winiarz, MD

  Independent Public Health Care Unit, Łęczna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 5, 2023
• Study Start: December 7, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)