Clinical assessment of a new catheter surface coating with antimicrobial properties: efficacy and effect of intensive catheter and exit site care education

ISRCTN	ISRCTN93939200
DOI	https://doi.org/10.1186/ISRCTN93939200
ClinicalTrials.gov (NCT)	NCT00621712
Protocol serial number	Study No 2007_MBR_001
Sponsor	Gambro Dialysatoren GmbH (Germany)
Funder	Gambro Dialysatoren GmbH (Germany)

Submission date: 30/08/2007
Registration date: 19/09/2007
Last edited: 14/02/2019

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 Dr. med. C. Erley
Scientific

Dr. med. B. Bader
St. Joseph-Krankenhaus
Baumerplan 24
Berlin
12101
Germany

Study information

Primary study design	Interventional
Study design	Prospective, randomised, single-centre, double-blind clinical study with two parallel patient groups (A and B) after prior sub-group stratification.
Secondary study design	Randomised controlled trial
Scientific title	Clinical assessment of a new catheter surface coating with antimicrobial properties: efficacy and effect of intensive catheter and exit site care education
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	180
Key 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
Key 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
Date of first enrolment	10/09/2007
Date of final enrolment	31/01/2009

Locations

Countries of recruitment

Germany

Study participating centre

Dr. med. B. Bader

Berlin
12101
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

Editorial Notes

14/02/2019: No publications found. Verifying results with principal investigator.