NCT06178835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

December 12, 2023

Last Update Submit

December 12, 2023

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

  • Incidence of delirium

    Development of postoperative delirium determined by validated evaluation tests.

    2 days post surgery, 5 days post surgery

Secondary Outcomes (1)

  • Inflammatory biomarker

    before surgery, after surgery, 3 days post surgery day 3

Study Arms (2)

Erythropoietin

EXPERIMENTAL

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

Drug: Erythropoietin

Control

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

ErythropoietinDRUG

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

Erythropoietin
normal salineDRUG

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.

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years and older
  • Patients scheduled for elective total knee arthroplasty, total hip arthroplasty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 39548414DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

ErythropoietinSaline Solution

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Bon-Nyeo Koo

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 21, 2023

Study Start

September 12, 2017

Primary Completion

July 28, 2019

Study Completion

August 28, 2019

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)