Clinical assessment of a new catheter surface coating with antimicrobial properties: safety - handling - efficacy
| ISRCTN | ISRCTN81821807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81821807 |
| Protocol serial number | 2005-MBR-001 |
| Sponsor | Gambro Corporate Research (Germany) |
| Funder | Gambro Corporate Research |
- 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
Scientific
Charité Campus Virchow-Klinikum
Innere Medizin
Nephrologie und Internistische Intensivmedizin
Augustenburger Platz 1
Berlin
13353
Germany
| ralf.schindler@charite.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Controlled, randomised, 2 parallel groups, multicenter |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Care BioBac |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
1. Safety (early removal due to catheter failure) |
| Key secondary outcome measure(s) |
1. Frequency of exit site and catheter-related bloodstream infections |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Need for renal replacement therapy 2. Age ≥18 years 3. Written informed consent |
| Key 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 |
| Date of first enrolment | 24/05/2004 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité Campus Virchow-Klinikum
Berlin
13353
Germany
13353
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
