EPO for Postop Delirium in Elderly Patients

December 12, 2023 updated by: Yonsei University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erythropoietin
500 IU/kg of EPO given intramuscularly 3 times for each patient
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.
Placebo Comparator: Control
Same amount of normal saline given intramuscularly 3 times for each patient
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delirium
Time Frame: 2 days post surgery, 5 days post surgery
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
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)
before surgery, after surgery, 3 days post surgery day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Bon-Nyeo Koo, Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Actual)

July 28, 2019

Study Completion (Actual)

August 28, 2019

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0694

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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