A Phase 4 interventional study of Erythropoietin and normal saline in Postoperative Delirium, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by Yonsei University · Phase 4, Interventional, and Prevention
Postoperative delirium is a common complication after surgery. The underlying pathophysiology of this complication is unclear, however neuroinflammation and oxidative stress secondary to surgery had shown to be the cause of postoperative cognitive dysfunction and delirium. Erythropoietin represents non-erythropoietic effects of anti-inflammatory properties. The aims of this study were to determine the role of erythropoietin toward the development of postoperative delirium, in terms of changes in inflammatory reaction by affecting the innate immunity in elderly patients undergoing total joint arthroplasty surgery.
1,058 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 76 is below the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 231 are open to participants now.
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Exclusion Criteria:
500 IU/kg of EPO given intramuscularly 3 times for each patient
Drug: Erythropoietin
Same amount of normal saline given intramuscularly 3 times for each patient
Drug: normal saline
500 IU/kg of erythropoietin is given 3 times for each patient: the day before surgery, start of surgery and on postoperative day 1.
The same amount of normal saline is given 3 times for each patient: the day before surgery, start of surgery and on postoperative day 1.
Incidence of delirium
Development of postoperative delirium determined by validated evaluation tests.
Time frame: 2 days post surgery, 5 days post surgery
Inflammatory biomarker
Preoperative and postoperative comparison of inflammatory biomarkers (IL-1, IL-6, TNF-a)
Time frame: before surgery, after surgery, 3 days post surgery day 3
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Yonsei University