Gangnam severance hospital
Seoul, 135-720, South Korea
NCT Number: NCT01369732
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.
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Notify Me20 year and older
All sexes
Interventional
Phase 4
Seoul, 135-720, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
Other names: epocaine
We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.
Other names: normal saline
Time frame: upto 7 days after surgery
Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.
Time frame: upto 7 days after surgery
Time frame: upto 1 month after surgery
Participants will be followed for the mortality, an expected average of 1 month after surgery.
Time frame: upto 2 weeks after surgery
Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.
Time frame: upto 2 weeks after surgery
Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.
Time frame: upto 1 month after surgery
Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.
Yonsei University
Other
Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
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