Prophylactic Antimicrobial Catheter Lock

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2010-01-31

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.

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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.

Conditions

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Bacteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

Catheter lock with heparin 1,000 units/mL

Group Type ACTIVE_COMPARATOR

Heparin 1000U/mL

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

4% Sodium Citrate with Gentamicin 320 mcg/mL

Intervention Type DRUG

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

Interventions

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Heparin 1000U/mL

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No