Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest

Study Overview
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Brief Summary
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During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. So, there has been considerable interest in the development of therapeutic strategies aimed at attenuating IR injury. One such group of agents that are attracting interest due to their potential protective effects on vascular endothelium is the erythropoietin. However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not been fully clarified. Therefore, the purpose of this study is to determine whether the prophylactic administration of erythropoietin reduce the incidence of acute kidney injury (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. The differences between the control and study groups are observed by clinical indicators such as serum creatinine, TNF-α, NGAL.

Official Title
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Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest

Conditions
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Dissection of Thoracic Aorta

Intervention / Treatment
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* Drug: recombinant human erythropoietin
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults above age of 20 Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest Exclusion Criteria: pregnancy or lactation cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis past history of thoracic aortic surgery malignancy 5. preoperative acute kidney injury chronic renal replacement therapy allergy or hypersensitivity to erythropoetin history of erythropoetin treatment death during or one day after surgery no consent reoperation within seven days of the first surgery

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline group<br>We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia. | Drug: saline<br>* We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.<br>* Other names: normal saline;|
| Experimental: erythropoietin group<br>We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. | Drug: recombinant human erythropoietin<br>* We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.<br>* Other names: epocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Acute Kidney Injury Based on RIFLE Criteria | Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery. | upto 7 days after surgery | 
| Incidence of Acute Kidney Injury Based on RIFLE Criteria |  | upto 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Participants will be followed for the mortality, an expected average of 1 month after surgery. | upto 1 month after surgery | 
| the Duration of Mechanical Ventilation | Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery. | upto 2 weeks after surgery | 
| the Duration of ICU Stay | Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery. | upto 2 weeks after surgery | 
| the Duration of Hospital Stay | Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery. | upto 1 month after surgery |