Prophylactic Antimicrobial Catheter Lock (ALLOCK)

This study has been completed.
Information provided by (Responsible Party):
John Moran, Satellite Healthcare Identifier:
First received: December 10, 2007
Last updated: December 15, 2011
Last verified: December 2011
The study is a randomized, double blinded, prospective, multicenter, clinical trial. All patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group will be less than the heparin arm.

Condition Intervention Phase
Drug: Heparin 1000U/mL
Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial

Resource links provided by NLM:

Further study details as provided by Satellite Healthcare:

Primary Outcome Measures:
  • Rate of device-related bacteremia [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection

Secondary Outcome Measures:
  • Rate of catheter clotting measured as requirement for tPA usage to maintain blood flow [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 303
Study Start Date: September 2003
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Catheter lock with heparin 1,000 units/mL
Drug: Heparin 1000U/mL
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
Active Comparator: 2
Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4%
Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.
  • Must be at least 18 years old
  • Compliant with a dialysis treatment schedule
  • Plans to continue hemodialysis treatment and follow-up at the investigational site
  • Must be able to care for the exit site independently or have someone who is able to care for the site for them
  • Must be able to sign the informed consent document

Exclusion Criteria:

  • The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred
  • Active exit site or tunnel infection
  • Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening
  • Known to have antibodies to heparin
  • Allergy to pork heparin
  • Allergy to gentamicin
  • Subject is pregnant
  • Known intravenous drug abuse
  Contacts and Locations
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Please refer to this study by its identifier: NCT00571259

United States, California
Satellite Healthcare, Inc
Mountain View, California, United States, 94041
Sponsors and Collaborators
Satellite Healthcare
Principal Investigator: Norman Coplon, MD Satellite Healthcare, Inc.
  More Information

Responsible Party: John Moran, Senior VP Clinical Affairs, Satellite Healthcare Identifier: NCT00571259     History of Changes
Other Study ID Numbers: SR001AL 
Study First Received: December 10, 2007
Last Updated: December 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Satellite Healthcare:
Sodium citrate
Central venous catheter

Additional relevant MeSH terms:
Bacterial Infections
Pathologic Processes
Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Citric Acid
Anti-Bacterial Agents
Calcium Chelating Agents
Chelating Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Sequestering Agents processed this record on May 23, 2016