Acute Kidney Injury, Cardiac Disease, Surgery
Conditions
Keywords
Erythropoietin, Cardiac Surgery Associated-acute Kidney Injury
Brief summary
To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney injury, and trying to provide evidence for protecting the renal function and improving the prognosis for patients after cardiac surgery.
Detailed description
Patients meet the inclusion criteria and agree to sign an informed consent will be randomly assigned into the control group or erythropoietin group.Interventions will be applied 1 day(24hrs) before the cardiac surgery. Blood and Urine samples will be collected after the surgery. By using the criterion given by KDIGO2012 and testing the biomarkers for acute kidney injury, we hope to find out if there is an association between erythropoietin administration and the occurence of acute kidney injury.
Interventions
DRUGErythropoietin
10000 IU erythropoietin, subcutaneous injection
DRUG0.9% sodium chloride
0.9% sodium chloride 1ml, subcutaneous injection
PROCEDUREcardiac surgery
included valve, coronary artery bypass graft or surgery for congenital heart diseases
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Preoperative hemoglobin\<130g/L; 2. Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases; 3. Volunteers with informed consent.
Exclusion criteria
1. Patients combined with infection; 2. Patients with end-stage renal disease and undergoing renal replacement therapy 3. Patients with the history of thromboembolism; 4. Patients with malignant tumor and undergoing chemotherapy; 5. Patients with unmanageable hypertension (systolic pressure\>200 mmHg or diastolic pressure\>110mmHg); 6. Patients allergic to erythropoietin; 7. Patients injected erythropoietin within 2 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Kidney Injury | 7 days | Occurrence of acute kidney injury according to KDIGO guideline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Renal Replacement Therapy | 3 months | suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery
0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases | 46 |
| Erythropoietin Group 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery
Erythropoietin: 10000 IU erythropoietin, subcutaneous injection
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | Erythropoietin Group | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 11 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 81 Participants | 40 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| serum creatinine | 76.0 μmo/L STANDARD_DEVIATION 26.2 | 75.2 μmo/L STANDARD_DEVIATION 26.6 | 74.5 μmo/L STANDARD_DEVIATION 27.6 |
| Sex: Female, Male Female | 28 Participants | 56 Participants | 28 Participants |
| Sex: Female, Male Male | 18 Participants | 36 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 10 / 46 | 9 / 46 |
Outcome results
Primary
Number of Participants With Acute Kidney Injury
Occurrence of acute kidney injury according to KDIGO guideline
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Number of Participants With Acute Kidney Injury | 15 participants |
| Erythropoietin Group | Number of Participants With Acute Kidney Injury | 9 participants |
Secondary
Number of Participants With Renal Replacement Therapy
suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Number of Participants With Renal Replacement Therapy | 0 participants |
| Erythropoietin Group | Number of Participants With Renal Replacement Therapy | 0 participants |