Overview

The Prevention of Contrast Induced Nephropathy by Sarpogrelate in Patients With Chronic Kidney Disease

Status:
Unknown status
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
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 clear defined and debatable. Therefore additional prophylactic pretreatments are needed. Methods/Design: 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) a routine treatment without sarpogrelate group (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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Boramae Hospital
Treatments:
Sarpogrelate
Criteria
Inclusion Criteria:

- patient with chronic kidney disease scheduled for coronary angiogram

Exclusion Criteria:

- age less than 20 years or more than 85 years

- liver cirrhosis greater than or equal to Child class B

- decreased serum platelet level (< 100,000/uL)

- patients who received or are schedule to receive percutaneous renal intervention

- currently are taking anticoagulation drugs

- unable to give informed consent