Hypothesis: B-Lock is a safe and effective catheter lock solution that will maintain catheter patency and reduce Central Line Associated Blood Stream Infections (CLABSI) in dialysis patients using a central venous catheter (CVC) for vascular access. The study is a prospective, randomized, site unblinded/sponsor blinded, clinical study of a minimum of 300 dialysis patients using a central venous catheter (CVC) for vascular access. Patients will be randomized 1:1 to receive either the investigational medical device (B-Lock or IMD) or active control heparin (5000 U/mL) (ACH) and observed for a minimum of 45 days or a maximum of 273 (expected average 160 days). IMD or ACH will be instilled into the catheter lumens (dual lumen catheters) at the end of each dialysis session and removed prior to the initiation of the next dialysis session. The primary objectives of this study are: * To demonstrate the safety of B-Lock in dialysis patients * To demonstrate the non-inferiority or, if proven to be non-inferior, superiority of B-Lock relative to ACH with respect to maintaining catheter patency as defined by the use of recombinant tissue plasminogen activator for maintaining adequate blood flow through the dialysis catheter * To demonstrate the superiority of B-Lock relative to ACH with respect to the incidence of CLABSI
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
270
Antimicrobial Catheter Lock Solution
Standard of Care Catheter Lock Solution
FMC Dialízis Központ Péterfy S. Kórház
Budapest, Hungary
FMC Dialízis Központ Szent István Kórház
Budapest, Hungary
FMC Szépvölgyi Dialízis Központ
Budapest, Hungary
DE OEC Nephrologiai Tanszék
Debrecen, Hungary
FMC Dialízis Központ Eger
Eger, Hungary
FMC Dialízis Központ Kecskemét
Kecskémet, Hungary
FMC Nefrológiai Központ Miskolc
Miskolc, Hungary
FMC Dialízis Központ Pécs
Pécs, Hungary
FMC Szatellita Dialízis Központ Pécs
Pécs, Hungary
Szegedi Tudományegyetem
Szeged, Hungary
...and 11 more locations
The number of adverse events (AEs), serious adverse events (SAEs) and device deficiencies (DDs) in the experimental and control populations
Time frame: 39 weeks
The number of thrombolytic treatment events in the experimental and control populations.
Thrombolytic treatments may be required to maintain catheter blood flow rates when blood flow is measured under standardized conditions and compared to blood flow at study entry. The number of treatment events in the experimental and control populations is inversely related to the ability of the lock solution to maintain catheter patency.
Time frame: 39 weeks
The number of Central Line Associated Blood Stream Infections (CLABSI events) in the experimental and control populations.
CLABSI is defined by the CDC as a documented blood stream infection (bacterial or fungal) in a patient with a CVC with no other source of infection identified by a qualified physician.
Time frame: 39 weeks
The number of Lock Solution Failures in the experimental and control populations.
"Lock Solution Failure" is defined as the sum of CLABSI events plus Occlusive Malfunction events. Occlusive malfunction is defined as the inability to return catheter blood flow rates to greater than 80% of baseline blood flow measrued at study entry under standardized conditions after treatment with tissue plasminogen activator (thrombolytic treatment).
Time frame: 39 weeks
The number of Occlusive Malfunction events in the experimental and control populations.
Time frame: 39 weeks
The number of lock solution aspirate cultures that are positive for bacterial or fungal growth in the experimental and control populations.
Time frame: 39 weeks
The number of catheters removed from the experimental and control patients that are found to have bacterial or fungal biofilm present inside the catheter lumen(s).
Time frame: 39 weeks
Catheter blood flow rates measured under standardized conditions over the duration of the study in the experimental and control populations.
Time frame: 39 weeks
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