Title
Prophylactic Antimicrobial Catheter Lock
Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial
Phase
Phase 4Lead Sponsor
Satellite HealthcareStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
BacteremiaIntervention/Treatment
sodium citrate heparin gentamicin ...Study Participants
303This 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.
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4%
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
| Event Type | Organ System | Event Term | 1: Heparin Lock | 2: Gentamicin Lock |
|---|
Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection
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.
