Condition category
Urological and Genital Diseases
Date applied
17/03/2006
Date assigned
24/03/2006
Last edited
24/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes