EPO for Postop Delirium in Elderly Patients

Study Overview
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Brief Summary
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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.

Official Title
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Erythropoietin for the Prevention of Postoperative Delirium in Elderly Patients Undergoing Total Joint Arthroplasty: Randomized Controlled Study

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Drug: Erythropoietin
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 years and older Patients scheduled for elective total knee arthroplasty, total hip arthroplasty Exclusion Criteria: Unable to communicate Cognitive impairment Unable to pre-screen delirium due to underlying central nervous system disease History of hypersensitivity related to erythropoietin and other anesthesia-related drugs History of myocardial infarction, pulmonary infarction, cerebral infarction, ischemic vascular disease, epilpesy, chronic liver disease, chronic kidney disease Uncontrolled high blood pressure Within one month of starting anti-hypertensive medication

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythropoietin<br>500 IU/kg of EPO given intramuscularly 3 times for each patient | Drug: Erythropoietin<br>* 500 IU/kg of erythropoietin is given 3 times for each patient: the day before surgery, start of surgery and on postoperative day 1.<br>|
| Placebo Comparator: Control<br>Same amount of normal saline given intramuscularly 3 times for each patient | Drug: normal saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium | Development of postoperative delirium determined by validated evaluation tests. | 2 days post surgery, 5 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory biomarker | Preoperative and postoperative comparison of inflammatory biomarkers (IL-1, IL-6, TNF-a) | before surgery, after surgery, 3 days post surgery day 3 |