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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00885300
Other study ID # 3705
Secondary ID
Status Completed
Phase N/A
First received April 20, 2009
Last updated April 20, 2009
Start date January 2008
Est. completion date September 2008

Study information

Verified date April 2009
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- hemodialysis for 3 months

- at least 2 time dialysis/week

Exclusion Criteria:

- active infection

- acute renal failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Iran, Islamic Republic of Shiraz University Hemodialysis Center Shiraz Fars

Sponsors (1)

Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary catheter infection 6 months Yes
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