Prophylactic Antimicrobial Catheter Lock

Satellite Healthcare303 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

303

Conditions

Bacteremia

Interventions

Heparin 1000U/mLDRUG

A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis

4% Sodium Citrate with Gentamicin 320 mcg/mLDRUG

A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Satellite Healthcare, Inc

Mountain View, California, United States

Outcomes

Primary Outcomes

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

Time frame: 5 years

Secondary Outcomes

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.

Time frame: 5 years

Data from ClinicalTrials.gov

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