EPO for Postop Delirium in Elderly Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06178835

Enrollment

Registered

2023-12-21

Start date

2017-09-12

Completion date

2019-08-28

Last updated

2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

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.

Interventions

DRUGErythropoietin

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

DRUGnormal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026