Prophylactic Antimicrobial Catheter Lock

Phase 4

Completed

• Conditions: Bacteremia
• Interventions: Drug: Heparin 1000U/mL; Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL

• Registration Number: NCT00571259
• Lead Sponsor: Satellite Healthcare

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2021-03-15
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Results First Posted: 2021-09-22
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Heparin 1000U/mL	Catheter lock with heparin 1,000 units/mL
2	4% Sodium Citrate with Gentamicin 320 mcg/mL	Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4%

Primary Outcome Measures

Name	Time	Method
Rate of Device-related Bacteremia	5 years	Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection

Secondary Outcome Measures

Name	Time	Method
Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow	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.

Trial Locations

Locations (1)

Satellite Healthcare, Inc; 🇺🇸 Mountain View, California, United States