Taurolidine-citrate vs heparin as catheter lock solutions in paediatric patients
| ISRCTN | ISRCTN86885538 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86885538 |
| Protocol serial number | EA2/084/06 |
| Sponsor | Tauropharm (Germany) |
| Funder | Tauropharm GmbH (Germany) |
- Submission date
- 07/12/2006
- Registration date
- 16/01/2007
- Last edited
- 08/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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 Uwe Querfeld
Scientific
Scientific
Department of Pediatric Nephrology
Charité Universitätsmedizin Berlin
Berlin
13353
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized prospective study in pediatric hospital with stratification for patients treated in renal/oncology/hematology departments |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Taurolock study |
| Study objectives | Use of taurolidine-citrate for catheter locking leads to a significant reduction of bacterial growth and catheter-related infections in paediatric patients with implanted central venous catheters |
| Ethics approval(s) | Approval received by local ethics committee (Ethikkommission 2 am Campus Virchow Klinikum) on 29 September 2006 (ref: EA2/084/06). |
| Health condition(s) or problem(s) studied | Catheter-related infections |
| Intervention | Taurolidine-citrate vs heparin as catheter lock solutions |
| Intervention type | Other |
| Primary outcome measure(s) |
Bacterial growth/biofilm formation in removed catheters |
| Key secondary outcome measure(s) |
Catheter-related infections, catheter occlusions |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | Paediatric patients with newly implanted central venous catheters |
| Key exclusion criteria | Bacteremia/sepsis ongoing; allergy against heparin or taurolidine |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Pediatric Nephrology
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 |