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NCT06178835 Clinical Trial

EPO for Postop Delirium in Elderly Patients

Postoperative Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06178835
Other study ID # 4-2017-0694
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 12, 2017
Est. completion date August 28, 2019

Study information
Verified date December 2023
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date August 28, 2019
Est. primary completion date July 28, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Erythropoietin
500 IU/kg of erythropoietin is given 3 times for each patient: the day before surgery, start of surgery and on postoperative day 1.
• normal saline
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.

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of delirium Development of postoperative delirium determined by validated evaluation tests. 2 days post surgery, 5 days post surgery
Secondary 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
See also
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Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
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Active, not recruiting NCT03291626 - Postoperative Delirium: EEG Markers of Sleep and Wakefulness
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