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Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT00885300
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : April 21, 2009
Sponsor:
Information provided by:
Shiraz University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Double Lumen Infection Hemodialysis Drug: cloxacillin Drug: heparin Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients
Study Start Date : January 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. catheter infection [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • active infection
  • acute renal failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: April 21, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Infection
Communicable Diseases
Calcium heparin
Heparin
Cloxacillin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents