AKI - Acute Kidney InjuryNCT05888376
A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
An observational study of AKI - Acute Kidney Injury and Acute Renal Failure, run by Vantive Health LLC at 2 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury, Acute Renal Failure, CKD
- What is being tested?
- Vascular access catheter to support dialysis or CRRT
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 2 sitesPoland
- Study dates
- 7 Dec 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Poland2 sites
Independent Public Health Care Unit, Łęczna
Łęczna, 21-010
Independent Public Hospital No. 4, Lublin
Lublin, 20-954
About this study
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:
- Duration of catheter use (survival)
- Reason(s) for catheter removal
Read the 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.
- Conditions
- AKI - Acute Kidney Injury, Acute Renal Failure, CKD, ESRD
- Being tested
- Vascular access catheter to support dialysis or CRRT
- Keywords
- extracorporeal blood purification, continuous renal replacement therapy
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Consecutive CKD including ESRD treatments | Consecutive retrospective treatments across all sites with a diagnosis of CKD, including ESRD Receives: 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) Receives: 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) Receives: Device: Vascular access catheter to support dialysis or CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter Survival
Confirm catheter lifetime related to GamCath HighFlow Dolphin Protect Catheter duration of use to support PMCF ongoing performance data
Measured: 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
Measured: 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
Collect real-world use data describing adverse events potentially related to the study catheter or catheter insertion/removal procedures
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start7 Dec 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Wojciech Dąbrowski, Prof MD PhD, Principal investigator, Independent Public Clinical Hospital No. 4, LublinMarek Winiarz, MD, Principal investigator, Independent Public Health Care Unit, Łęczna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888376
- Sponsor's protocol ID
- BXU565389
- Status last verified
- Mar 2025
- First submitted
- 15 May 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The Sponsor is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, the Sponsor will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP). Research requests will be reviewed by qualified medical and scientific experts within the company. If the Sponsor agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of the Sponsor prior to the release of any data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
- ClinicalTrials.gov ID
- NCT05888376
- Acronym / sponsor ID
- BXU565389
- Conditions
- AKI - Acute Kidney Injury, Acute Renal Failure, CKD, ESRD
- Keywords
- extracorporeal blood purification, continuous renal replacement therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Duration of catheter use (survival)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Consecutive CKD including ESRD treatments | – | Device: Vascular access catheter to support dialysis or CRRTConsecutive retrospective treatments across all sites with a diagnosis of CKD, including ESRD |
| Consecutive treatments with minimum hospital stay of 20 days | – | Device: Vascular access catheter to support dialysis or CRRTConsecutive retrospective treatments across all sites with a minimum hospital stay of days (excluding cases previously identified; may be acute or chronic disease) |
| Consecutive acute/chronic kidney disease treatments | – | Device: Vascular access catheter to support dialysis or CRRTConsecutive retrospective treatments across all sites with acute or chronic disease (excluding cases previously identified) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular access catheter to support dialysis or CRRTA specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT | Device | Consecutive CKD including ESRD treatments, Consecutive acute/chronic kidney disease treatments, Consecutive treatments with minimum hospital stay of 20 days |
Primary outcome
Catheter Survival
Time frame: 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
Confirm catheter lifetime related to GamCath HighFlow Dolphin Protect Catheter duration of use to support PMCF ongoing performance data
Reason(s) for Catheter Removal
Time frame: Within 72 hours of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks
Collect additional real-world use data describing the reason(s) for GamCath HighFlow Dolphin Protect Catheter removal to support PMCF ongoing product safety performance
1 secondary outcome
Adverse Events
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No. The Sponsor is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, the Sponsor will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP). Research requests will be reviewed by qualified medical and scientific experts within the company. If the Sponsor agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of the Sponsor prior to the release of any data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wojciech Dąbrowski, Prof MD PhD principal investigator
Independent Public Clinical Hospital No. 4, Lublin
Marek Winiarz, MD principal investigator
Independent Public Health Care Unit, Łęczna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AKI - Acute Kidney Injury and Acute Renal Failure, run by Vantive Health LLC at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter Survival (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.