EPO for Postop Delirium in Elderly Patients

NCT ID: NCT06178835

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2019-08-28

Brief Summary

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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

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Conditions

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Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Erythropoietin

500 IU/kg of EPO given intramuscularly 3 times for each patient

Group Type EXPERIMENTAL

Erythropoietin

Intervention Type 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.

Control

Same amount of normal saline given intramuscularly 3 times for each patient

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bon-Nyeo Koo

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim EJ, Park KK, Choi SY, Ju HM, Kim TL, Kim J, Kim SY, Koo BN. Erythropoietin for the prevention of postoperative neurocognitive disorder in older adult patients undergoing total joint arthroplasty: a randomized controlled study. BMC Anesthesiol. 2024 Nov 15;24(1):418. doi: 10.1186/s12871-024-02770-9.

Reference Type DERIVED
PMID: 39548414 (View on PubMed)

Other Identifiers

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4-2017-0694

Identifier Type: -

Identifier Source: org_study_id