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Trials
Published in: Trials 1/2010

Open Access 01-12-2010 | Study protocol

The prevention of contrast induced nephropathy by sarpogrelate in patients with chronic kidney disease: a study protocol for a prospective randomized controlled clinical trial

Authors: Kyungil Park, Woo-Young Chung, Jae-Bin Seo, Sang-Hyun Kim, Joo-Hee Zo, Myung-A Kim, Young-Bae Park

Published in: Trials | Issue 1/2010

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Abstract

Background

Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, their efficacy is not clearly defined and debatable. Therefore additional prophylactic pretreatments are needed.

Methods/Design

The present study aims to investigate differences in occurrence of CIN after sarpogrelate premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85 years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to one of two conditions: (i) routine treatment without sarpogrelate, and (ii) routine treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the occurrence of CIN during 4 weeks after receiving contrast agent.

Discussion

As of May 2010, there were no registered trials evaluating the therapeutic potentials of sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.

Trial registration

NCT01165567
Appendix
Available only for authorised users
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Metadata
Title
The prevention of contrast induced nephropathy by sarpogrelate in patients with chronic kidney disease: a study protocol for a prospective randomized controlled clinical trial
Authors
Kyungil Park
Woo-Young Chung
Jae-Bin Seo
Sang-Hyun Kim
Joo-Hee Zo
Myung-A Kim
Young-Bae Park
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Trials / Issue 1/2010
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-11-122

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