Ex vivo microbiological assessment of an anti-biofilm catheter in acute dialysis application

ISRCTN	ISRCTN39140035
DOI	https://doi.org/10.1186/ISRCTN39140035
ClinicalTrials.gov number	NCT00621114
Secondary identifying numbers	Study No 2007_MBR_003

Submission date: 30/08/2007
Registration date: 19/09/2007
Last edited: 01/02/2019

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. Teut Risler
Scientific

Dr. med. Bjorn Friedrich
Universitatsklinikum Tübingen
Medizinische Klinik, Abteilung IV
Sektion fur Nieren- und Hochdruckkrankheiten
Otfried-Muller-Strasse 10
Tubingen
72076
Germany

Study information

Study design	Prospective, randomised, single-centre, clinical study with 2 parallel patient groups (A and B) after prior sub-group stratification.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title	Ex vivo microbiological assessment of an anti-biofilm catheter in acute dialysis application
Study objectives	The clinical study aims at providing further data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating but with identical design.
Ethics approval(s)	Approval was granted by the local medical ethics committee (Ethikkommission der Medizinischen Fakultat der Eberhard-Karls-Universitat und am Universitatsklinikum Tubingen) on 25th July 2007 (ref:154/2007MPG1).
Health condition(s) or problem(s) studied	Renal disease
Intervention	Commercially available catheters will be used; the design will not be blinded. Catheters will be placed according to a defined protocol. The investigator selects the appropriate catheter length for each patient. Type X: Standard double lumen catheter without coating: commercially available CE certified GamCath® catheter (Gambro Kathetertechnik Hechingen, Germany), Product codes: GDHK-1315J (outer diameter 13 French, length 15 cm, curved extension lines), GDHK-1320J (outer diameter 13 French, length 20 cm, curved extension lines) Type Y: Double lumen catheter with bismuth-containing coating: commercially available, CE certified GamCath Dolphin® Protect catheter (Gambro Kathetertechnik Hechingen, Germany) with similar design and measures as the standard catheter, but with antibacterial coating, Product codes: MC-GDHK-1315J (outer diameter 13 French, length 15 cm, curved extension lines), MC-GDHK-1320J (outer diameter 13 French, length 20 cm, curved extension lines). Catheters will be removed based on clinical indication; therefore there is no exact duration of treatment. There will be no follow-up blood investigations for the patient. The maximal observation period is 29 days. Used catheters and arterial and venous rinsing fluids will be analysed for bacterial colonisation. A cut-off 100 CFU/mL will be defined as positive. Further characterisation of bacteria will be performed with focus on genetic variations of bacteria that might be attributed to inhibition or resistance mechanisms on the catheters. Citrate plasma and lock solution samples will be analysed for bismuth concentrations by Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Routine clinical laboratory data will be analysed according to local clinical laboratory routine.
Intervention type	Other
Primary outcome measure	1. Bacterial colonisation of the catheter surface, analysed after removal of the catheter. A cut-off 100 CFU/mL will be defined as positive 2. Bismuth content in plasma and lock solution will be analysed before catheter placement, once weekly pre-dialysis and once at explantation
Secondary outcome measures	1. Catheter patency (indirect measure: venous and arterial pressure differences) 2. Catheter dwell time 3. Exit site appearance 4. Blood parameters Secondary outcome measured will be documented at routine sampling.
Overall study start date	08/08/2007
Completion date	31/03/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	69 patients with need for renal replacement therapy will be included in the study in a first approach.
Key inclusion criteria	1. Need for extracorporeal renal replacement therapy (acute and chronic renal failure) 2. Anticipated duration of dialysis therapy less than or equal to 30 days 3. Age between 18 and 85 years 4. Written informed consent
Key exclusion criteria	1. Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection 2. Known pregnancy
Date of first enrolment	08/08/2007
Date of final enrolment	31/03/2008

Locations

Countries of recruitment

Germany

Study participating centre

Dr. med. Bjorn Friedrich

Tubingen
72076
Germany

Sponsor information

Gambro Dialysatoren GmbH (Germany)
Industry

Holger-Crafoord-Str. 26
Hechingen
72379
Germany

Website	http://www.gambro.com/Portal.aspx?id=8644
"ROR"	https://ror.org/05jgtkc28

Funders

Funder type

Industry

Gambro Dialysatoren GmbH (Germany) - grant

No information available

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) - Activities are part of the BMBF BioProfile project "Antibakterielle und biofunktionale Oberflachen fur extrakorporale sowie zelltherapeutische Verfahren" (ref: Forderkennzeichen 0313648)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

01/02/2019: No publications found, verifying study status with the principal investigator