Prophylactic Antimicrobial Catheter Lock

Bacteremia Clinical Trial

— ALLOCK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571259
• Other study ID #: SR001AL
• Status: Completed
• Phase: Phase 4
• Start date: September 2003
• Est. completion date: January 2010

Study information

• Verified date: September 2021
• Source: Satellite Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia

Intervention

Drug:
• Heparin 1000U/mL
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
• 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

Locations

Country	Name	City	State
United States	Satellite Healthcare, Inc	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years
Secondary	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.	5 years