Prophylactic Antimicrobial Catheter Lock (ALLOCK)

Satellite Healthcare

Status and phase: Completed; Phase 4

Conditions: Bacteremia

Treatments: Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL; Drug: Heparin 1000U/mL

Study type: Interventional

Funder types: Other

Identifiers

NCT00571259

SR001AL

Details and patient eligibility

About

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

Full 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.

Enrollment: 303 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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303 participants in 2 patient groups

1

Active Comparator group

Description:

Catheter lock with heparin 1,000 units/mL

Treatment:

Drug: Heparin 1000U/mL

2

Active Comparator group

Description:

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

Treatment:

Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL