Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients

NCT ID: NCT00885300

Last Updated: 2009-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to investigate whether cloxacillin lock is effective in prevention of double lumen infection.

Detailed Description

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Double lumen infection is one of the causes of morbidity and mortality in hemodialysis patients. Many strategies used to prevent it and one of them is antibiotic lock. Thus we select chronic hemodialysis patients and divided them into 2 groups. One group received cloxacillin and heparin as catheter lock and the second group received only heparin lock.

Conditions

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Double Lumen Infection Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

cloxacillin 100 mg/ml + heparin 1000iu/ml as catheter lock at the end of hemodialysis

Group Type EXPERIMENTAL

cloxacillin

Intervention Type DRUG

cloxacillin 100mg/ml as catheter lock at the end of hemodialysis

heparin

Intervention Type DRUG

heparin 1000iu/ml as catheter lock at the end of hemodialysis

2

heparin 1000iu/ml as catheter lock at the end of hemodialysis

Group Type ACTIVE_COMPARATOR

heparin

Intervention Type DRUG

heparin 1000iu/ml as catheter lock at the end of hemodialysis

Interventions

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cloxacillin

cloxacillin 100mg/ml as catheter lock at the end of hemodialysis

Intervention Type DRUG

heparin

heparin 1000iu/ml as catheter lock at the end of hemodialysis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* hemodialysis for 3 months
* at least 2 time dialysis/week

Exclusion Criteria

* active infection
* acute renal failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shiraz University of Medical Science

Principal Investigators

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maryam pakfetart, assistant professor

Role: STUDY_CHAIR

Shiraz nephro-urology research center

Locations

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Shiraz University Hemodialysis Center

Shiraz, Fars, Iran

Site Status

Countries

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Iran

References

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Unver S, Atasoyu EM, Evrenkaya TR, Ardic N, Ozyurt M. Risk factors for the infections caused by temporary double-lumen hemodialysis catheters. Arch Med Res. 2006 Apr;37(3):348-52. doi: 10.1016/j.arcmed.2005.07.010.

Reference Type BACKGROUND
PMID: 16513483 (View on PubMed)

Other Identifiers

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3705

Identifier Type: -

Identifier Source: org_study_id

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