- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00862966
Central Venous Catheter Lock Solution (CVCLS)
March 13, 2009 updated by: University Medical Center, Tuzla
Randomized Control Trial on Citrate as the Central Venous Catheter Lock Solution
The purpose of this study is to determine whether the application of 47% citrate lock solution decreases the incidence of infection and thrombosis of central venous catheter in hemodialysis population.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
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
-
-
TK
-
Tuzla, TK, Bosnia and Herzegovina, 75000
- Department of Dialysis
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of end stage renal disease
Exclusion Criteria:
- Patients refusing randomization
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: citrate
|
comparison of different catheter lock solutions
|
|
Active Comparator: heparin
|
comparison of different lock solutions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
lower incidence of infection
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
lower incidence of thrombosis
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2009
Primary Completion (Anticipated)
April 1, 2010
Study Registration Dates
First Submitted
March 13, 2009
First Submitted That Met QC Criteria
March 13, 2009
First Posted (Estimate)
March 17, 2009
Study Record Updates
Last Update Posted (Estimate)
March 17, 2009
Last Update Submitted That Met QC Criteria
March 13, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMC-02-139
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.