Kidney Failure, Renal Failure
Conditions
Keywords
Erythropoietin, Erythropoetin, Cardiac surgery, Ischemia, Reperfusion, Renal function, Cystatin C, Creatinine, Safety
Brief summary
The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.
Detailed description
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.
Interventions
DRUGErythropoietin zeta
The active drug will be given only once after the anesthesia induction and before the start of surgery. The active drug will be diluted to 2000U/kg and given as a single dose of 400U/kg. The dose will be prepared prior to surgery by a independent nurse.
DRUGPlacebo
Placebo arm will receive NaCl 9mg/ml with a dose of 0.2 ml/kg. The placebo dose will be prepared prior to the surgery by a independent nurse. The calculated volume will match the volume of the active durg.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in plasma cystatin C measured on day 3 postoperatively. | 3 days postoperatively |
Countries
Sweden
Outcome results
None listed