Antibiotic Lock Solutions in the Prevention of Catheter Related Bacteremia

This study has been completed.

First Received on February 21, 2006. No Changes Posted

Sponsor:	Henry Ford Health System
Information provided by:	Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT00294502

Purpose

To study the efficacy of an antibacterial/anticoagulant solution instilled into the hemodialysis (HD) catheters after each treatment (“antibiotic lock solution - ALS”) to prevent catheter related bacteremia (CRB) and to salvage catheters with established CRB.

Condition	Intervention	Phase
ESRD	Drug: Gentamycin/citrate, Minocycline/EDTA	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Minocycline Minocycline hydrochloride Gentamicins

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:

Incidence of symptomatic CRB

Estimated Enrollment:	120
Study Start Date:	September 2003
Estimated Study Completion Date:	May 2004

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

ESRD patients with tunnelled catheters

Exclusion Criteria:

patients on IV abx for infections, patients who have AV graft, AV fistulas

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294502

Locations

United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202

Sponsors and Collaborators

Henry Ford Health System

Investigators

Principal Investigator:

Antanole Bearabe, MD

Henry Ford Hospital

More Information

Publications:

Allon M. Dialysis catheter-related bacteremia: treatment and prophylaxis. Am J Kidney Dis. 2004 Nov;44(5):779-91. Review.

Dogra GK, Herson H, Hutchison B, Irish AB, Heath CH, Golledge C, Luxton G, Moody H. Prevention of tunneled hemodialysis catheter-related infections using catheter-restricted filling with gentamicin and citrate: a randomized controlled study. J Am Soc Nephrol. 2002 Aug;13(8):2133-9.

ClinicalTrials.gov Identifier:	NCT00294502 History of Changes
Other Study ID Numbers:	3008
Study First Received:	February 21, 2006
Last Updated:	February 21, 2006
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Gentamicins
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012