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Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00885300
First received: April 20, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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


Condition Intervention
Double Lumen Infection
Hemodialysis
 Drug: cloxacillin
Drug: heparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • catheter infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
cloxacillin 100 mg/ml + heparin 1000iu/ml as catheter lock at the end of hemodialysis
 Drug: cloxacillin
cloxacillin 100mg/ml as catheter lock at the end of hemodialysis
Drug: heparin
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
 Drug: heparin
heparin 1000iu/ml as catheter lock at the end of hemodialysis

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • active infection
  • acute renal failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885300

Locations
Iran, Islamic Republic of
Shiraz University Hemodialysis Center
Shiraz, Fars, Iran, Islamic Republic of, o98-711
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Chair: maryam pakfetart, assistant professor Shiraz nephro-urology research center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Office of Vice Chancellor for research in Shiraz UMS, Shiraz University of Medical Science
ClinicalTrials.gov Identifier: NCT00885300     History of Changes
Other Study ID Numbers: 3705
Study First Received: April 20, 2009
Last Updated: April 20, 2009
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Cloxacillin
Calcium heparin
Heparin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013