Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00621712
Protocol/serial number
Study No 2007_MBR_001
Study information
Scientific title
Acronym
Study hypothesis
Efficacy of a catheter with antibacterial surface coating in preventing central venous catheter-related infection in comparison to standard catheters without coating but with identical design, and effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.
Ethics approval
Approval was granted by the Freiburger Ethikkommission International on 23rd April 2007 (ref: FECI code 07/1371). Furthermore, the study was submitted to the Local Ethics Committee: Charite - Universitatsmedizin Berlin Ethikkommission for consultation according to physicians professional regulations.
Study design
Prospective, randomised, single-centre, double-blind clinical study with two parallel patient groups (A and B) after prior sub-group stratification.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Renal disease
Intervention
A prospective, randomised, single-centre, double-blind clinical study with two parallel patient groups (A and B) will be conducted. All patients will be examined for nasal Methicillin Resistant Staphylococcus Aureus (MRSA) carriage at inclusion into the study.
Stratification for the following subgroups wil be performed:
1. MRSA positive patients
2. MRSA negative patients
3. Patients with unknown MRSA status
Patients in group A will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891). Patients in group B will be treated with a commercially available and CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671).
In study phase I including 90 patients, the study will be conducted without additional hygiene training. Catheter and exit site care will be provided according to the standard procedures in the study centre. In study phase II, which will start after an intensive education of catheter care and hygiene for the nursing staff, another 90 patients will be included.
Study endpoints are bacterial colonisation after removal of the catheter (primary endpoint), surface deposits of thrombogenic activity (indirect measure: venous and arterial pressure differences), catheter survival, exit site appearance and blood parameters. Additionally, reasons for catheter removal will be precisely documented and analysed.
The following parameters will be documented:
1. The patient's medical history
2. Catheter handling during insertion
3. Catheter manipulations
4. Care of insertion site
5. Bloodstream and exit site infections
6. Heparin dose
7. Blood flow rate during dialysis
8. Venous and arterial pressures during dialysis
9. Body temperature
10. Treatment duration
11. Blood counts: blood analysis once weekly at start of dialysis sessions
12. Coagulation parameters Partial Thromboplastin Time (PTT), Anti-Thrombin III (AT III) and Procalcitonin (PCT): blood analysis once weekly at start of dialysis sessions
13. C-Reactive Protein (CRP) and fibrinogen: blood analysis at start of each dialysis session
14. Bismuth analysis in plasma before implantation of the catheter, at start and end of the first dialysis session, once weekly at start of the following dialysis sessions and at explantation of the catheter
15. Bismuth analysis from the lock-solution before start of each dialysis treatment
16. Number of treatments before catheter removal
17. Catheter dwell time
18. Detailed description of reasons for catheter removal
19. Catheter handling during removal
Used catheters and arterial and venous rinsing fluids will be analysed for bacterial contamination. Citrate plasma and lock solution samples will be analysed for bismuth concentrations by Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Blood samples for analysis in the study centre will be taken and analysed according to the local routine procedures (blood counts, PTT, AT III, PCT, fibrinogen).
The maximal observation period per patient is 29 days.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Bacterial colonisation of the catheter surface.
The time points of catheter analysis cannot be given exactly as these analyses are done after removal of the catheter and removal is determined by medical indication not influenced by the study protocol. The other sampling points and number of analyses are also depending on the individual patients treatment regimen. The maximal observation period is 29 days.
Secondary outcome measures
1. Surface deposits of thrombogenic activity
2. Catheter survival
3. Exit site appearance
4. Blood parameters:
4.1. Blood counts: blood analysis once weekly at start of dialysis sessions
4.2. Coagulation parameters PTT, AT III and PCT: blood analysis once weekly at start of dialysis sessions
4.3. CRP and fibrinogen: blood analysis at start of each dialysis session
4.4. Bismuth analysis in plasma before implantation of the catheter, at start and end of the first dialysis session, once weekly at start of the following dialysis sessions and at explantation of the catheter
4.5. Bismuth analysis from the lock-solution before start of each dialysis treatment
The time points of catheter analysis cannot be given exactly as these analyses are done after removal of the catheter and removal is determined by medical indication not influenced by the study protocol. The other sampling points and number of analyses are also depending on the individual patients treatment regimen. The maximal observation period is 29 days.
Overall trial start date
10/09/2007
Overall trial end date
31/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
2. Age over 18 years
3. Written informed consent
4. Needed catheter length 15 cm or 20 cm
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
180
Participant exclusion criteria
1. Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
2. Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
3. Bacteremia with a former catheter within 10 days prior to catheter implantation
4. Known pregnancy
5. Lactation
6. Participation in another clinical study during the preceding 30 days
Recruitment start date
10/09/2007
Recruitment end date
31/01/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Dr. med. B. Bader
Berlin
12101
Germany
Sponsor information
Organisation
Gambro Dialysatoren GmbH (Germany)
Sponsor details
Holger-Crafoord-Str. 26
Hechingen
72379
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Gambro Dialysatoren GmbH (Germany)
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
Basic results (scientific)
Publication list