NCT00294502

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
Last Updated

February 22, 2006

Status Verified

September 1, 2003

First QC Date

February 21, 2006

Last Update Submit

February 21, 2006

Conditions

ESRD

Outcome Measures

Primary Outcomes (1)

  • Incidence of symptomatic CRB

Interventions

Gentamycin/citrate, Minocycline/EDTADRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ESRD patients with tunnelled catheters

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

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

    PMID: 15492943RESULT

  • 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. doi: 10.1097/01.asn.0000022890.29656.22.

    PMID: 12138146RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

GentamicinsCitric Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Antanole Bearabe, MD

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

September 1, 2003

Study Completion

May 1, 2004

Last Updated

February 22, 2006

Record last verified: 2003-09

Locations

US(1)