Clinical assessment of a new catheter surface coating with antimicrobial properties: safety - handling - efficacy

ISRCTN ISRCTN81821807
DOI https://doi.org/10.1186/ISRCTN81821807
Secondary identifying numbers 2005-MBR-001
Submission date
17/03/2006
Registration date
24/03/2006
Last edited
24/03/2006
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ralf Schindler
Scientific

Charité Campus Virchow-Klinikum
Innere Medizin
Nephrologie und Internistische Intensivmedizin
Augustenburger Platz 1
Berlin
13353
Germany

Email ralf.schindler@charite.de

Study information

Study designControlled, randomised, 2 parallel groups, multicenter
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymCare BioBac
Study objectivesShow 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(s)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.
Health condition(s) or problem(s) studiedEnd-stage renal disease patients with need for a temporary hemodialysis catheter
InterventionComparison of standard temporary hemodialysis catheter with a new catheter with antibacterial/anti-biofilm coating
Intervention typeOther
Primary outcome measure1. Safety (early removal due to catheter failure)
2. Handling (implantation, removal)
3. Efficacy (hemodialysis blood flow rate, pressure)
Secondary outcome measures1. Frequency of exit site and catheter-related bloodstream infections
2. Bacterial growth on the catheter
3. Inflammatory and coagulation parameters in plasma
Overall study start date24/05/2004
Completion date01/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. Need for renal replacement therapy
2. Age ≥18 years
3. Written informed consent
Key exclusion criteria1. 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
Date of first enrolment24/05/2004
Date of final enrolment01/07/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Charité Campus Virchow-Klinikum
Berlin
13353
Germany

Sponsor information

Gambro Corporate Research (Germany)
Industry

Holger-Crafoord Street 26
Hechingen
72379
Germany

Email reinhold.deppisch@gambro.com
ROR logo "ROR" https://ror.org/05jgtkc28

Funders

Funder type

Industry

Gambro Corporate Research

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan