Ischaemic heart disease Circulatory System Ischaemia
Conditions
Interventions
Erytropoietin versus placebo in coronary artery bypass graft surgery
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. First-time coronary artery bypass surgery 2. Age >70 3. Serum creatinine >120 µmol/l 4. Diabetes mellitus (diet or medication controlled)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in creatine calculated clearance between preoperative baseline and postoperative day one | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oliguria 2. Acute renal failure requiring dialysis 3. Urinary analysis of N-acetyl-BD-glucosaminidase and alpha-1 microglobulin/creatinine ratio 4. Evidence of cardiac injury (troponin I) 5. Neurological injury S-100 6. Evidence of type I neurological outcome (stroke, transient ischaemic attack [TIA]) 7. Type II neurological outcome (new deterioration in intellectual function, confusion, agitation, disorientation, memory deficit or seizure) | — |
Countries
United Kingdom
Outcome results
None listed