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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline group | Placebo Comparator | We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia. |
|
| erythropoietin group | Experimental | We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human erythropoietin | Drug | We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yon Hee Shim | Yonsei University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam severance hospital | Seoul | 135-720 | South Korea |
Six patients were dropped out regarding wrong dose-count of erythropoietin (n = 1), death within 24 hours after surgery (n = 2), and screening failure due to chronic kidney disease (n = 3).
This study was conducted at the university hospital between May 2011 and January 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Saline Group | We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia. |
| FG001 | Erythropoietin Group | We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline Group | We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia. |
| BG001 | Erythropoietin Group | We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Not Posted | upto 7 days after surgery | ||||||||||||
| Secondary | Mortality | Participants will be followed for the mortality, an expected average of 1 month after surgery. | Not Posted | upto 1 month after surgery |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saline Group | We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yon Hee Shim | Yonsei University College of Medicine | 82220193547 | tren125@yuhs.ac |
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| ID | Term |
|---|---|
| D000094629 | Dissection, Thoracic Aorta |
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| saline | Drug | We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia. |
|
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | the Duration of Mechanical Ventilation | Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery. | Not Posted | upto 2 weeks after surgery |
| Secondary | the Duration of ICU Stay | Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery. | Not Posted | upto 2 weeks after surgery |
| Secondary | the Duration of Hospital Stay | Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery. | Not Posted | upto 1 month after surgery |
| Primary | Incidence of Acute Kidney Injury Based on RIFLE Criteria | Posted | Number | participants | upto 7 days after surgery |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Erythropoietin Group | We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. | 0 | 0 | 0 | 0 |
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| D002318 |
| Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |