Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery
|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).
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|