Contact information
Type
Scientific
Primary contact
Prof Ralf Schindler
ORCID ID
Contact details
Charité Campus Virchow-Klinikum
Innere Medizin
Nephrologie und Internistische Intensivmedizin
Augustenburger Platz 1
Berlin
13353
Germany
ralf.schindler@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2005-MBR-001
Study information
Scientific title
Acronym
Care BioBac
Study hypothesis
Show that safety, handling and efficacy of a new temporary hemodialysis catheter with antibacterial/anti-biofilm coating is equal or superior compared to standard catheters of same type
Ethics approval
Primary vote given by Charite, Berlin on 08/03/2004, reference number: 30/2004; secondary votes given by Arztekammer Westfalen-Lippe on 04/05/2004, reference number: 4/134 and Technical University Munich on 02/06/2004, reference number: 1080/04.
Study design
Controlled, randomised, 2 parallel groups, multicenter
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
End-stage renal disease patients with need for a temporary hemodialysis catheter
Intervention
Comparison of standard temporary hemodialysis catheter with a new catheter with antibacterial/anti-biofilm coating
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Safety (early removal due to catheter failure)
2. Handling (implantation, removal)
3. Efficacy (hemodialysis blood flow rate, pressure)
Secondary outcome measures
1. Frequency of exit site and catheter-related bloodstream infections
2. Bacterial growth on the catheter
3. Inflammatory and coagulation parameters in plasma
Overall trial start date
24/05/2004
Overall trial end date
01/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Need for renal replacement therapy
2. Age ≥18 years
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Known acute hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
2. Age >75 years
3. Any infection associated wtih one or more positive blood cultures within 10 days prior to planned implantation
4. Any bacteremia associated with a previous catheter
5. Known pregnancy
6. Hospitalisation for more than 14 days
7. Respiratory assist
8. Use of antibiotics
9. Participation in another study during the preceding 30 days
Recruitment start date
24/05/2004
Recruitment end date
01/07/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Charité Campus Virchow-Klinikum
Berlin
13353
Germany
Sponsor information
Organisation
Gambro Corporate Research (Germany)
Sponsor details
Holger-Crafoord Street 26
Hechingen
72379
Germany
reinhold.deppisch@gambro.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Gambro Corporate Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary