Clinical trial NCT05888376: A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
Official title: A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AKI - Acute Kidney Injury
Acute Renal Failure
CKD
ESRD
Keywords: extracorporeal blood purification
continuous renal replacement therapy
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2023-06-05
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Catheter Survival
timeFrame: 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
measure: Reason(s) for Catheter Removal
timeFrame: Within 72 hours of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 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
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Independent Public Hospital No. 4, Lublin
city: Łęczna
country: Poland
facility: Independent Public Health Care Unit, Łęczna
Study officials:
affiliation: Independent Public Clinical Hospital No. 4, Lublin
name: Wojciech Dąbrowski, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent Public Health Care Unit, Łęczna
name: Marek Winiarz, MD
role: PRINCIPAL_INVESTIGATOR
References: