Overview

Vascular Protective Effect of Rosuvastatin in Arteriovenous Fistula

Status:
Completed
Trial end date:
2019-01-31
Target enrollment:
0
Participant gender:
All
Summary
Background Arteriovenous (AV) fistula is the most common vascular access for long-term hemodialysis in the end-stage renal disease (ESRD) patients. About 25% of these patients are diabetes mellitus. However, the effects of hyperglycemia on the vascular function of arteriovenous fistula are still remained unclear. Studies have shown that blood flow in the AV fistula is significantly reduced in patients with diabetes mellitus. Diabetic patients also require a longer period of time for the maturation of AV fistula, and have slightly higher complication rate than non-diabetic patients. Statins have been widely shown to mediate several important pleiotropic effects in the improvement of vascular endothelial dysfunction, attenuation of inflammatory responses, stabilization of atherosclerotic plaques, inhibition of vascular smooth muscle proliferation, and modulation of procoagulant activity and platelet function.Our experimental studies in diabetic animals demonstrate that administration of a water-soluble statin rosuvastatin significantly improves the fistula flow, vascular function and luminal dilatation of AV fistula in diabetic rats by suppression of vascular oxidative stress and inflammatory load. Study hypothesis The central hypothesis of this research project is rosuvastatin mediates pleiotropic protective effect on vascular endothelial function and suppresses the regional pro-inflammatory reaction in the vasculature, therefore administration of rosuvastatin during the perioperative period of creation of native AV fistulas in diabetic patients with ESRD may potentiate the vascular function and reduce the primary failure rate of AV fistulae.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Cheng-Kung University Hospital
Treatments:
Rosuvastatin Calcium
Criteria
Inclusion Criteria:

1. Patients with diabetes mellitus (postprandial blood sugar >140 mg/dl)

2. Patients with end-stage kidney disease and is proposed to undertake chronic
hemodialysis

3. Patients of age 18-65 years

4. The fistula is constructed in the forearm (radiocephalic fistula).

Exclusion Criteria:

1. Preoperative blood sugar level >250 mg/dl or most recent HbA1c >10%

2. Recent treatment with statins within 2 weeks before evaluation for clinical trial

3. Advanced liver disease

4. Chronic alcoholism

5. Congestive heart failure

6. Coronary disease which require permanent statin therapy

7. Malignancy or hematologic disorder

8. Pregnancy or breastfeeding

9. Past history of creation of AV fistula

10. Scheduled for general anesthesia

11. Emergent operation

12. peripheral arterial occlusion disease