Prophylactic Antimicrobial Catheter Lock (ALLOCK)

September 21, 2021 updated by: Satellite Healthcare

Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial

This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94041
        • Satellite Healthcare, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Device-related Bacteremia
Time Frame: 5 years
Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow
Time Frame: 5 years
The rate of thrombolytic agent use required to maintain blood flow adequate for dialysis was used as an objective measure of clinically significant catheter clotting.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satellite Healthcare

Investigators

  • Principal Investigator: Norman Coplon, MD, Satellite Healthcare, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR001AL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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