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Prophylactic Antimicrobial Catheter Lock

Information source: Satellite Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacteremia

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

Phase: Phase 4

Status: Completed

Sponsored by: Satellite Healthcare

Official(s) and/or principal investigator(s):
Norman Coplon, MD, Principal Investigator, Affiliation: Satellite Healthcare, Inc.

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Rate of device-related bacteremia

Secondary outcome: Rate of catheter clotting measured as requirement for tPA usage to maintain blood flow

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Satellite Healthcare, Inc, Mountain View, California 94041, United States
Additional Information

Starting date: September 2003
Last updated: December 15, 2011

Page last updated: August 23, 2015

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