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Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients

Primary Purpose

Double Lumen Infection, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
cloxacillin
heparin
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Double Lumen Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • active infection
  • acute renal failure

Sites / Locations

  • Shiraz University Hemodialysis Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

catheter infection

Secondary Outcome Measures

Full Information

First Posted
April 20, 2009
Last Updated
April 20, 2009
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00885300
Brief Title
Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients
Official Title
Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Double Lumen Infection, Hemodialysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
cloxacillin 100 mg/ml + heparin 1000iu/ml as catheter lock at the end of hemodialysis
Arm Title
2
Arm Type
Active Comparator
Arm Description
heparin 1000iu/ml as catheter lock at the end of hemodialysis
Intervention Type
Drug
Intervention Name(s)
cloxacillin
Intervention Description
cloxacillin 100mg/ml as catheter lock at the end of hemodialysis
Intervention Type
Drug
Intervention Name(s)
heparin
Intervention Description
heparin 1000iu/ml as catheter lock at the end of hemodialysis
Primary Outcome Measure Information:
Title
catheter infection
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: hemodialysis for 3 months at least 2 time dialysis/week Exclusion Criteria: active infection acute renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maryam pakfetart, assistant professor
Organizational Affiliation
Shiraz nephro-urology research center
Official's Role
Study Chair
Facility Information:
Facility Name
Shiraz University Hemodialysis Center
City
Shiraz
State/Province
Fars
ZIP/Postal Code
o98-711
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16513483
Citation
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.
Results Reference
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Learn more about this trial

Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients

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