Prophylactic Antimicrobial Catheter Lock

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bacteremia

Intervention / Treatment
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* Drug: Heparin 1000U/mL
* Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Catheter lock with heparin 1,000 units/mL | Drug: Heparin 1000U/mL<br>* A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis<br>|
| Active Comparator: 2<br>Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4% | Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL<br>* A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sodium citrate, Gentamicin, Prophylaxis, Hemodialysis, Central venous catheter