Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery
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|ClinicalTrials.gov Identifier: NCT01758861|
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : January 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Drug: EPO group Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||October 2012|
Experimental: EPO group
EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.
Drug: EPO group
Other Name: EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.
Placebo Comparator: Placebo group
Placebo group received normal saline via intravenous bolus administration after induction of anesthesia.
- incidence of acute kidney injury [ Time Frame: change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5 ]The diagnostic criteria for AKI is followed by AKIN criteria (absolutely increase in the SCr concentration ≥ 0.3 mg/dL from baseline, ≥ 50% increase in the SCr concentration within 48 hours after operation).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758861
|Korea, Republic of|
|Department of anesthesiology and pain medicine Yonsei University College of Medicine|
|Seoul, Korea, Republic of, 120-752|