The use of erythropoietin in cardiac surgery to protect against ischaemia-related injury in kidney and other organ systems
- Conditions
- Ischaemic heart diseaseIschaemiaCirculatory System
- Registration Number
- ISRCTN89080534
- Lead Sponsor
- HS Greater Glasgow and Clyde (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 84
1. First-time coronary artery bypass surgery
2. Age >70
3. Serum creatinine >120 µmol/l
4. Diabetes mellitus (diet or medication controlled)
1. Hypersensitiviy to mammalian cell-derived products to (human) albumin, to EPO or any of the ingredients of EPO
2. Hypercoagulability
3. Significant psychiatric or neurological disease that would prevent adherence to the requirements of the protocol
4. Immunosuppression immunocompromised (including, but not limited to aquired immune deficiency syndrome (AIDS) and immunosuppressive therapy)
5. Significant hepatic disturbance
6. Chronic renal impairment (requiring haemodialysis or peritoneal dialysis)
7. Pregnant or breast feeding
8. Current treatment with human recombitant erythropoietin
9. Previous cardiac surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in creatine calculated clearance between preoperative baseline and postoperative day one
- Secondary Outcome Measures
Name Time Method 1. Oliguria<br>2. Acute renal failure requiring dialysis<br>3. Urinary analysis of N-acetyl-BD-glucosaminidase and alpha-1 microglobulin/creatinine ratio<br>4. Evidence of cardiac injury (troponin I)<br>5. Neurological injury S-100<br>6. Evidence of type I neurological outcome (stroke, transient ischaemic attack [TIA])<br>7. Type II neurological outcome (new deterioration in intellectual function, confusion, agitation, disorientation, memory deficit or seizure)