The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury

Study Overview
=================
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.

Official Title
-----------------
The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury, Cardiac Disease, Surgery

Intervention / Treatment
-----------------
* Drug: Erythropoietin
* Drug: 0.9% sodium chloride
* Procedure: cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preoperative hemoglobin<130g/L; Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases; Volunteers with informed consent. Exclusion Criteria: Patients combined with infection; Patients with end-stage renal disease and undergoing renal replacement therapy Patients with the history of thromboembolism; Patients with malignant tumor and undergoing chemotherapy; Patients with unmanageable hypertension (systolic pressure>200 mmHg or diastolic pressure>110mmHg); Patients allergic to erythropoietin; Patients injected erythropoietin within 2 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery | Drug: 0.9% sodium chloride<br>* 0.9% sodium chloride 1ml, subcutaneous injection<br>* Other names: saline solution;Procedure: cardiac surgery<br>* included valve, coronary artery bypass graft or surgery for congenital heart diseases<br>* Other names: open-heart surgery;|
| Experimental: Erythropoietin group<br>10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery | Drug: Erythropoietin<br>* 10000 IU erythropoietin, subcutaneous injection<br>* Other names: EPO;Procedure: cardiac surgery<br>* included valve, coronary artery bypass graft or surgery for congenital heart diseases<br>* Other names: open-heart surgery;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Acute Kidney Injury | Occurrence of acute kidney injury according to KDIGO guideline | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erythropoietin, Cardiac Surgery Associated-acute Kidney Injury