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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00862966
Other study ID # UMC-02-139
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 13, 2009
Last updated March 13, 2009
Start date April 2009

Study information

Verified date March 2009
Source University Medical Center, Tuzla
Contact Goran Imamovic, MD, PhD
Phone +387 61 194 131
Email goran_imamovic@bih.net.ba
Is FDA regulated No
Health authority Bosnia: Federal Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of end stage renal disease

Exclusion Criteria:

- Patients refusing randomization

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
citrate
comparison of different catheter lock solutions
heparin
comparison of different lock solutions

Locations

Country Name City State
Bosnia and Herzegovina Department of Dialysis Tuzla TK

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center, Tuzla

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type Measure Description Time frame Safety issue
Primary lower incidence of infection 1 year Yes
Secondary lower incidence of thrombosis 1 year Yes
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