- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00885300
Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients
April 20, 2009 updated by: Shiraz University of Medical Sciences
The purpose of this study is to investigate whether cloxacillin lock is effective in prevention of double lumen infection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fars
-
Shiraz, Fars, Iran, Islamic Republic of, o98-711
- Shiraz University Hemodialysis Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- hemodialysis for 3 months
- at least 2 time dialysis/week
Exclusion Criteria:
- active infection
- acute renal failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
cloxacillin 100 mg/ml + heparin 1000iu/ml as catheter lock at the end of hemodialysis
|
cloxacillin 100mg/ml as catheter lock at the end of hemodialysis
heparin 1000iu/ml as catheter lock at the end of hemodialysis
|
|
Active Comparator: 2
heparin 1000iu/ml as catheter lock at the end of hemodialysis
|
heparin 1000iu/ml as catheter lock at the end of hemodialysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
catheter infection
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: maryam pakfetart, assistant professor, Shiraz nephro-urology research center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
April 20, 2009
First Submitted That Met QC Criteria
April 20, 2009
First Posted (Estimate)
April 21, 2009
Study Record Updates
Last Update Posted (Estimate)
April 21, 2009
Last Update Submitted That Met QC Criteria
April 20, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3705
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.