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Efficacy Study to Evaluate B-Lock™ as an Antimicrobial Lock Solution in Dialysis Patients With a CVC

NCT01989091 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2017-02-27

No results posted yet for this study

Summary

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

Conditions

  • Dialysis Catheter Infections

Interventions

DEVICE

B-Lock

Antimicrobial Catheter Lock Solution

DRUG

Heparin 5,000 U/mL

Standard of Care Catheter Lock Solution

Sponsors & Collaborators

  • Great Lakes Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • John C Cheronis, MD PhD · Great Lakes Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Hungary
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01989091 on ClinicalTrials.gov