A Phase 4 interventional study of recombinant human erythropoietin and saline in Dissection of Thoracic Aorta, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-09-26.
Sponsored by Yonsei University · Phase 4, Interventional, and Prevention
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.
1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.
This study's enrollment of 66 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
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Exclusion Criteria:
We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
Drug: saline
We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
Drug: recombinant human erythropoietin
We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
Also known as: epocaine
We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.
Also known as: normal saline
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
Incidence of Acute Kidney Injury Based on RIFLE Criteria
Time frame: upto 7 days after surgery
Mortality
Participants will be followed for the mortality, an expected average of 1 month after surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: upto 1 month after surgery
This study was conducted at the university hospital between May 2011 and January 2013.
| Milestone | Saline Group | Erythropoietin Group |
|---|---|---|
| Started | 33 | 33 |
| Completed | 29 | 31 |
| Not completed | 4 | 2 |
Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.
Results for this outcome have not been posted.
Participants will be followed for the mortality, an expected average of 1 month after surgery.
Results for this outcome have not been posted.
Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.
Results for this outcome have not been posted.
Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.
Results for this outcome have not been posted.
Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.
Results for this outcome have not been posted.
| participants | Saline Group | Erythropoietin Group |
|---|---|---|
| Incidence of Acute Kidney Injury Based on RIFLE Criteria | 18 | 18 |
Non-serious events are listed at a 1.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Saline Group | — | — | — |
| Erythropoietin Group | — | — | — |
| Age, Categorical(Participants) | Saline Group | Erythropoietin Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 20 | 37 |
| >=65 years | 16 | 13 | 29 |
| Age Continuous(years) | Saline Group | Erythropoietin Group | Total |
|---|---|---|---|
| Mean | 65 ± 12 | 61 ± 13 | 63 ± 13 |
| Sex: Female, Male(Participants) | Saline Group | Erythropoietin Group | Total |
|---|---|---|---|
| Female | 11 | 20 | 31 |
| Male | 22 | 13 | 35 |
| Region of Enrollment(participants) | Saline Group | Erythropoietin Group | Total |
|---|---|---|---|
| Korea, Republic of | 33 | 33 | 66 |
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Yonsei University