Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.

The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.

Acute kidney injury is a common complication after cardiac surgery and is associated with decreased long-term survival.

Several experimental and animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of high dose erythropoietin. Clinical studies in human have also suggested that high dose erythropoietin has preconditioning effects against injury after ischemia and reperfusion on different organs in human, such as brain, heart, liver, and kidneys.

Administration of Epo in high doses in conjunction with cardiac surgery has shown to be safe with no direct side-effects.

The investigators therefore hypothesize that a preconditioning effect of erythropoietin before cardiac surgery can reduce the level of renal dysfunction after surgery in a group with preoperative renal impairment.

Inclusion Criteria:

• The patient is scheduled for non-emergent CABG surgery.
• CyC eGFR or MDRD eGFR < 60 ml/min.
• The patient has given his/her written consent to participate

Exclusion Criteria:

• The patient has an uncontrolled hypertension.
• Hypersensitivity to the active drug.
• The patient is pregnant or is a fertile woman (<50 years).
• The patient has been treated with Erythropoietin within 4 weeks prior to the surgery.
• Preoperative CyC eGFR or MDRD eGFR is < 15, or the patient is treated with dialysis.
• The patient has a known malignancy.
• The patient is planned for Off-pump CABG surgery.
• The patient is included in other ongoing clinical trial. Yes / No
• Clinically judgment by the investigator that the patient should not participate in the study.