| Trial ID: | L1506 |
| Source ID: | NCT01863914
|
| Associated Drug: |
Rosuvastatin
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| Title: |
Vascular Protective Effect of Rosuvastatin in Arteriovenous Fistula
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
End-stage Kidney Disease|Diabetes Mellitus|Arteriovenous Fistula
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| Interventions: |
DRUG: Rosuvastatin
|
| Outcome Measures: |
Primary: Primary patent rate of AV fistula, The definition of primary patency of an AV fistula is defined as successful cannulation of the fistula for first hemodialysis treatment (first dialysis session)(reference: BioMed Central Nephrology 2013;14:79). Administration of rosuvastatin protects the endothelial function in the AV fistula and restores the blood flow rate in the shunt of diabetic patients with ESRD, thereby improves the primary patent rate and early maturation of these fistulas, 6 months after operation | Secondary: Composite outcome measurement of the overall shunt-related complication rate, The most commonly shunt-related complications are formation of aneurysms, failure of shunt to mature, and development of thrombosis in AV fistula (Ann Vasc Surg 2012;26:680). The occurrence of shunt-related complications usually require surgical reintervention. Administration of rosuvastatin improves the vascular function of AV fistulas in diabetic patients with ESRD, therefore reduces the overall shunt-related complication rate and the requirement for surgical re-interventions., 6 months after operation | Other: Composite outcome measurement of systemic pro-inflammatory response, Systemic proinflammatory response is determined by measuring blood concentrations of monocyte chemo-attractant protein (MCP)-1, interleukin (IL)-1 beta, IL-6 and tumor necrosis factor (TNF)-alpha, and the numbers of circulating endothelial progenitor cells (EPCs). Administration of rosuvastatin is associated with reduction of the systemic pro-inflammatory response and oxidative stress (levels of proinflammatory cytokines and other mediators in the circulation) in diabetic patients with ESRD. On the other hand, administration of rosuvastatin may mobilize the bone marrow-derived EPCs into systemic circulation, and the number of these circulating endothelial progenitors may provide prognostic value to the outcomes of AV fistula., 6 months after operation
|
| Sponsor/Collaborators: |
Sponsor: National Cheng-Kung University Hospital
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2012-11
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| Completion Date: |
2019-01-31
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| Results First Posted: |
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| Last Update Posted: |
2019-02-19
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| Locations: |
National Cheng Kung University Hospital, Tainan, 704, Taiwan
|
| URL: |
https://clinicaltrials.gov/show/NCT01863914
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