Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Renal Failure AKI - Acute Kidney Injury CKD ESRD

Keywords

extracorporeal blood purificationcontinuous 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

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 CRRTDevice

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 treatmentsConsecutive acute/chronic kidney disease treatmentsConsecutive treatments with minimum hospital stay of 20 days

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

Sponsors & Collaborators

Baxter Healthcare Corporation
Industrycollaborator
Vantive Health LLC
Industrylead

Study Sites (2)

Independent Public Hospital No. 4, Lublin

Lublin, 20-954, Poland

Independent Public Health Care Unit, Łęczna

Łęczna, 21-010, Poland

MeSH Terms

Conditions

Acute Kidney InjuryKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological 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

Enrollment

76 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (3)

Consecutive CKD including ESRD treatments

Consecutive treatments with minimum hospital stay of 20 days

Consecutive acute/chronic kidney disease treatments

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (3)

Consecutive CKD including ESRD treatments

Consecutive treatments with minimum hospital stay of 20 days

Consecutive acute/chronic kidney disease treatments

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations