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Prophylactic Antimicrobial Catheter Lock (ALLOCK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Moran, Satellite Healthcare
ClinicalTrials.gov Identifier:
NCT00571259
First received: December 10, 2007
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Bacteremia
 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:

U.S. FDA Resources

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571259

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

No publications provided

Responsible Party: John Moran, Senior VP Clinical Affairs, Satellite Healthcare
ClinicalTrials.gov 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
Gentamicin
Prophylaxis
Hemodialysis
Central venous catheter

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Infective Agents
Gentamicins
Citric Acid
Heparin
Therapeutic Uses
 Pharmacologic Actions
Anticoagulants
Hematologic Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013