Dissection of Thoracic Aorta
Conditions
Brief summary
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.
Interventions
DRUGrecombinant human erythropoietin
We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
DRUGsaline
We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults above age of 20 2. Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest
Exclusion criteria
1. pregnancy or lactation 2. cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis 3. past history of thoracic aortic surgery 4. malignancy 5. preoperative acute kidney injury 5. chronic renal replacement therapy 6. allergy or hypersensitivity to erythropoetin 7. history of erythropoetin treatment 8. death during or one day after surgery 9. no consent 10. reoperation within seven days of the first surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Acute Kidney Injury Based on RIFLE Criteria | upto 7 days after surgery | Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Duration of ICU Stay | upto 2 weeks after surgery | Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery. |
| the Duration of Hospital Stay | upto 1 month after surgery | Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery. |
| the Duration of Mechanical Ventilation | upto 2 weeks after surgery | Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery. |
| Mortality | upto 1 month after surgery | Participants will be followed for the mortality, an expected average of 1 month after surgery. |
Countries
South Korea
Participant flow
Recruitment details
This study was conducted at the university hospital between May 2011 and January 2013.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Saline Group We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia. | 33 |
| Erythropoietin Group We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | Erythropoietin Group | Saline Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 16 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 17 Participants | 37 Participants |
| Age Continuous | 61 years STANDARD_DEVIATION 13 | 65 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 13 |
| Region of Enrollment Korea, Republic of | 33 participants | 33 participants | 66 participants |
| Sex: Female, Male Female | 20 Participants | 11 Participants | 31 Participants |
| Sex: Female, Male Male | 13 Participants | 22 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: upto 7 days after surgery
Primary
Incidence of Acute Kidney Injury Based on RIFLE Criteria
Time frame: upto 7 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saline Group | Incidence of Acute Kidney Injury Based on RIFLE Criteria | 18 participants |
| Erythropoietin Group | Incidence of Acute Kidney Injury Based on RIFLE Criteria | 18 participants |
Secondary
Mortality
Participants will be followed for the mortality, an expected average of 1 month after surgery.
Time frame: upto 1 month 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.
Time frame: upto 1 month 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.
Time frame: upto 2 weeks after surgery
Secondary
the Duration of Mechanical Ventilation
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