EPO for Postop Delirium in Elderly Patients

Phase 4

Completed

• Conditions: Postoperative Delirium
• Interventions: Drug: normal saline; Drug: Erythropoietin

• Registration Number: NCT06178835
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-12
• Primary Completion: 2019-07-28
• Study Completion: 2019-08-28
• Status Verified: 2023-12
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	normal saline	Same amount of normal saline given intramuscularly 3 times for each patient
Erythropoietin	Erythropoietin	500 IU/kg of EPO given intramuscularly 3 times for each patient

Primary Outcome Measures

Name	Time	Method
Incidence of delirium	2 days post surgery, 5 days post surgery	Development of postoperative delirium determined by validated evaluation tests.

Secondary Outcome Measures

Name	Time	Method
Inflammatory biomarker	before surgery, after surgery, 3 days post surgery day 3	Preoperative and postoperative comparison of inflammatory biomarkers (IL-1, IL-6, TNF-a)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea; 🇰🇷 Seoul, Korea, Republic of