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Completed

NCT Number: NCT06178835

EPO for Postop Delirium in Elderly Patients

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.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin

Drug

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

Drug

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.

Primary outcomes

  1. Incidence of delirium

    Time frame: 2 days post surgery, 5 days post surgery

    Development of postoperative delirium determined by validated evaluation tests.

Secondary outcomes

  1. Inflammatory biomarker

    Time frame: before surgery, after surgery, 3 days post surgery day 3

    Preoperative and postoperative comparison of inflammatory biomarkers (IL-1, IL-6, TNF-a)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2023
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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