HemodialysisABBANCT00621114
Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application
A study testing GamCath® central venous catheter and GamCath Dolphin® Protect central venous catheter in people with Hemodialysis, run by Vantive Health LLC at 1 site in Germany.
Trial summary
The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- GamCath® central venous catheter and GamCath Dolphin® Protect central venous catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Jul 2009
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- central venous catheter placement
- Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
- Anticipated duration of dialysis therapy less than or equal to 30 days
- Age between 18 and 85 years
- Written informed consent
Who cannot join
- Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating.
Read the detailed description
Central venous catheters are increasingly used to provide long-term venous access, e.g. after failure of the primary arteriovenous fistula, and they are the first choice in case of an acute need for extracorporeal therapy. Microbial adhesions and biofilm formation have been implicated in serious infections associated with the use of indwelling catheters.
In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed.
The clinical study described below aims at providing further data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections.
- Conditions
- Hemodialysis
- Being tested
- GamCath® central venous catheter, GamCath Dolphin® Protect central venous catheter
- Keywords
- Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamCath® central venous catheterDevice
Also called GamCath® catheter
Choice of central venous catheter type
GamCath Dolphin® Protect central venous catheterDevice
Also called GamCath Dolphin® Protect
Choice of central venous catheter type
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients in group 1 will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891). Receives: Device: GamCath® central venous catheter |
| 2 | Experimental | Patients in group 2 will be treated with a CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671). Receives: Device: GamCath Dolphin® Protect central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial colonisation of the catheter surface
Measured: after explantation
Secondary outcomes (4)
venous and arterial pressure
Measured: during dialysis
catheter dwell time
Measured: at explantation
exit site appearance
Measured: at routine catheter care
blood parameters
Measured: during dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Teut Risler, Prof. Dr., Principal investigator, Universitaetsklinikum Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621114
- Sponsor's protocol ID
- Study No 2007_MBR_003
- Other IDs
- ISRCTN39140035
- Acronym
- ABBA
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2008
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
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
- Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application
- ClinicalTrials.gov ID
- NCT00621114
- Acronym / sponsor ID
- ABBA / Study No 2007_MBR_003
- Conditions
- Hemodialysis
- Keywords
- Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Study start
- Aug 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- 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 clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating.
Detailed description
Central venous catheters are increasingly used to provide long-term venous access, e.g. after failure of the primary arteriovenous fistula, and they are the first choice in case of an acute need for extracorporeal therapy. Microbial adhesions and biofilm formation have been implicated in serious infections associated with the use of indwelling catheters.
In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed.
The clinical study described below aims at providing further data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: GamCath® central venous catheterPatients in group 1 will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891). |
| 2 | Experimental | Device: GamCath Dolphin® Protect central venous catheterPatients in group 2 will be treated with a CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- central venous catheter placement
- Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
- Anticipated duration of dialysis therapy less than or equal to 30 days
- Age between 18 and 85 years
- Written informed consent
Key exclusion criteria (2 listed)
- Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection
- Known pregnancy
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 |
|---|---|---|
| GamCath® central venous catheterAlso: GamCath® catheterChoice of central venous catheter type | Device | 1 |
| GamCath Dolphin® Protect central venous catheterAlso: GamCath Dolphin® ProtectChoice of central venous catheter type | Device | 2 |
Primary outcome
Bacterial colonisation of the catheter surface
Time frame: after explantation
4 secondary outcomes
venous and arterial pressure
Time frame: during dialysis
catheter dwell time
Time frame: at explantation
exit site appearance
Time frame: at routine catheter care
blood parameters
Time frame: during dialysis
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.
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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.
Teut Risler, Prof. Dr. principal investigator
Universitaetsklinikum Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GamCath® central venous catheter and GamCath Dolphin® Protect central venous catheter in people with Hemodialysis, run by Vantive Health LLC at 1 site in Germany.
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 5 inclusion and 2 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 1 site in Germany. 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?
Bacterial colonisation of the catheter surface (time frame: after explantation). 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.