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Prophylactic Antimicrobial Catheter Lock (ALLOCK)

Primary Purpose

Bacteremia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Heparin 1000U/mL
4% Sodium Citrate with Gentamicin 320 mcg/mL
Sponsored by
Satellite Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacteremia focused on measuring Sodium citrate, Gentamicin, Prophylaxis, Hemodialysis, Central venous catheter

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Satellite Healthcare, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Catheter lock with heparin 1,000 units/mL

Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4%

Outcomes

Primary Outcome Measures

Rate of Device-related Bacteremia
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
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.

Full Information

First Posted
December 10, 2007
Last Updated
September 21, 2021
Sponsor
Satellite Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00571259
Brief Title
Prophylactic Antimicrobial Catheter Lock
Acronym
ALLOCK
Official Title
Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Satellite Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
Keywords
Sodium citrate, Gentamicin, Prophylaxis, Hemodialysis, Central venous catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Catheter lock with heparin 1,000 units/mL
Arm Title
2
Arm Type
Active Comparator
Arm Description
Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4%
Intervention Type
Drug
Intervention Name(s)
Heparin 1000U/mL
Intervention Description
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
Intervention Type
Drug
Intervention Name(s)
4% Sodium Citrate with Gentamicin 320 mcg/mL
Intervention Description
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
Primary Outcome Measure Information:
Title
Rate of Device-related Bacteremia
Description
Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman Coplon, MD
Organizational Affiliation
Satellite Healthcare, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satellite Healthcare, Inc
City
Mountain View
State/Province
California
ZIP/Postal Code
94041
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Prophylactic Antimicrobial Catheter Lock

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