Kidney Failure, Acute
Conditions
Brief summary
The purpose of this study is to determine whether erythropoietin is effective in preventing acute kidney dysfunction after coronary artery bypass grafting surgery.
Detailed description
Acute kidney injury (AKI) occurs in 7% to 40% of patients undergoing cardiac surgery, depending on the definition of AKI used. Even small increments in serum creatinine have been shown to be associated with increased mortality after cardiac surgery. However, there are no proven interventions to prevent AKI after cardiac surgery. Erythropoietin (EPO) has been shown to have tissue-protective effects in various experimental models. In this prospective placebo-controlled randomized trial, we evaluated the effectiveness of EPO in the prevention of AKI after coronary artery bypass grafting (CABG).
Interventions
DRUGErythropoietin-Beta
300 IU/kg of EPO or saline intravenously before surgery
DRUGNormal Saline
300 IU/kg of normal saline intravenously before surgery
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for elective CABG over age 18
Exclusion criteria
* Under age 18 * Emergent CABG * Prior exposure to nephrotoxic drug * Dialysis patients * Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had AKI (Acute Kidney Injury) | at any time within the first 5 days after surgery | number of participants who had 50% increase in serum creatinine levels from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Estimated Glomerular Filtration Rate (eGFR) | during the first 5 days after surgery | estimated glomerular filtration rate (eGFR)as ml/min/1.73m2 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erythropoietin (EPO) Group received 300 U/kg of erythropoietin intraveously following induction of anesthesia | 36 |
| Placebo Group received normal saline intraveously following induction of anesthesia | 35 |
| Total | 71 |
Baseline characteristics
| Characteristic | Placebo Group | Erythropoietin (EPO) Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 21 Participants | 21 Participants | 42.0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 15 Participants | 29.0 Participants |
| Age Continuous | 69 years STANDARD_DEVIATION 8 | 65 years STANDARD_DEVIATION 11 | 67 years STANDARD_DEVIATION 10 |
| Region of Enrollment Korea, Republic of | 35 participants | 36 participants | 71.0 participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 18.0 Participants |
| Sex: Female, Male Male | 23 Participants | 30 Participants | 53.0 Participants |
Outcome results
Primary
Number of Participants Who Had AKI (Acute Kidney Injury)
number of participants who had 50% increase in serum creatinine levels from baseline
Time frame: at any time within the first 5 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erythropoietin (EPO) Group | Number of Participants Who Had AKI (Acute Kidney Injury) | 3 participants |
| Placebo Group | Number of Participants Who Had AKI (Acute Kidney Injury) | 10 participants |
Secondary
Change in Estimated Glomerular Filtration Rate (eGFR)
estimated glomerular filtration rate (eGFR)as ml/min/1.73m2
Time frame: during the first 5 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erythropoietin (EPO) Group | Change in Estimated Glomerular Filtration Rate (eGFR) | -1.5 ml/min/1.73m2 | Standard Deviation 7.3 |
| Placebo Group | Change in Estimated Glomerular Filtration Rate (eGFR) | -9.1 ml/min/1.73m2 | Standard Deviation 14.5 |