Renal InsufficiencyNCT00621712
Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties
A study testing GamCath® central venous catheter and GamCath Dolphin® Protect central venous catheter in people with Renal Insufficiency, run by Vantive Health LLC at 1 site in Germany.
Trial summary
The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency
- 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
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Dec 2010
- 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 years and older
- 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)
- Age over 18 years
- Written informed consent
- Needed catheter length 15 cm or 20 cm
Who cannot join
- Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
- Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
- Bacteremia with a former catheter within 10 days prior to catheter implantation
- Known pregnancy
- Lactation
- Participation in another clinical study during the preceding 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education
The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.
Read the detailed description
The risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. To address this problem, efforts have focused on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation.
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.
Among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections.
The clinical study aims at providing data on antimicrobial efficiency of the 2 types of CE certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-related infections.
- Conditions
- Renal Insufficiency
- Being tested
- GamCath® central venous catheter, GamCath Dolphin® Protect central venous catheter
- Keywords
- Renal Dialysis, Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis
- Medical subject headings
- Renal Insufficiency
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, No. CE 76891
choice of catheter type
GamCath Dolphin® Protect central venous catheterDevice
Also called GamCath Dolphin® Protect, No.CE 90671
choice of catheter type
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients in group A 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 |
| B | Experimental | Patients in group B 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: at explantation
Secondary outcomes (4)
Surface deposits of thrombogenic activity
Measured: at explantation
Catheter survival
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 startOct 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 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
- Christiane M Erley, Prof. Dr., Principal investigator, St. Joseph-Krankenhaus Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621712
- Sponsor's protocol ID
- Study No 2007_MBR_001
- Other IDs
- ISRCTN93939200
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2008
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Schults JA, Kleidon T, Charles K, Young ER, Ullman AJ. Peripherally inserted central catheter design and material for reducing catheter failure and complications. Cochrane Database Syst Rev. 2024 Jun 28;6(6):CD013366. doi: 10.1002/14651858.CD013366.pub2.
PubMed 38940297
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
- Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education
- ClinicalTrials.gov ID
- NCT00621712
- Acronym / sponsor ID
- Study No 2007_MBR_001
- Conditions
- Renal Insufficiency
- Keywords
- Renal Dialysis, Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (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 study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.
Detailed description
The risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. To address this problem, efforts have focused on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation.
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.
Among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections.
The clinical study aims at providing data on antimicrobial efficiency of the 2 types of CE certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-related infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: GamCath® central venous catheterPatients in group A will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891). |
| B | Experimental | Device: GamCath Dolphin® Protect central venous catheterPatients in group B 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 years and older
- 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)
- Age over 18 years
- Written informed consent
- Needed catheter length 15 cm or 20 cm
Key exclusion criteria (6 listed)
- Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
- Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
- Bacteremia with a former catheter within 10 days prior to catheter implantation
- Known pregnancy
- Lactation
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® catheter, No. CE 76891choice of catheter type | Device | A |
| GamCath Dolphin® Protect central venous catheterAlso: GamCath Dolphin® Protect, No.CE 90671choice of catheter type | Device | B |
Primary outcome
Bacterial colonisation of the catheter surface
Time frame: at explantation
4 secondary outcomes
Surface deposits of thrombogenic activity
Time frame: at explantation
Catheter survival
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.
- Derived from this study: PubMed 38940297Schults JA, Kleidon T, Charles K, Young ER, Ullman AJ. Peripherally inserted central catheter design and material for reducing catheter failure and complications. Cochrane Database Syst Rev. 2024 Jun 28;6(6):CD013366. doi: 10.1002/14651858.CD013366.pub2.
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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.
Christiane M Erley, Prof. Dr. principal investigator
St. Joseph-Krankenhaus Berlin
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 Renal Insufficiency, 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 6 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: at explantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00621712, which also lists 1 linked publication.
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.