NCT00571259

Prophylactic Antimicrobial Catheter Lock

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Satellite Healthcare · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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

• Bacteremia

Interventions

Type	Name	Description
DRUG	Heparin 1000U/mL	A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
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

Timeline

• Start date: 2003-09-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-12-11
• Last updated: 2021-09-22
• Results posted: 2021-09-22

Locations

1 site across 1 country: United States