Clinical Trials Logo
  1. Home
  2. Postoperative Delirium
  3. NCT06178835
  4. Details
NCT06178835 Clinical Trial

EPO for Postop Delirium in Elderly Patients

Postoperative Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06178835
Other study ID # 4-2017-0694
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 12, 2017
Est. completion date August 28, 2019

Study information
Verified date December 2023
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date August 28, 2019
Est. primary completion date July 28, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of delirium Development of postoperative delirium determined by validated evaluation tests. 2 days post surgery, 5 days post surgery
Secondary Inflammatory biomarker Preoperative and postoperative comparison of inflammatory biomarkers (IL-1, IL-6, TNF-a) before surgery, after surgery, 3 days post surgery day 3
See also
  Status Clinical Trial Phase
Completed NCT03606941 - Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery N/A
Recruiting NCT05990790 - The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium Phase 4
Completed NCT03950440 - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Completed NCT02585128 - Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation N/A
Recruiting NCT02227225 - Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly N/A
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Terminated NCT00455143 - Cognitive Protection - Dexmedetomidine and Cognitive Reserve Phase 4
Recruiting NCT05010148 - A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain Phase 3
Recruiting NCT05992506 - Electroencephalographic Biomarker to Predict Postoperative Delirium
Recruiting NCT03839784 - Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Completed NCT04154176 - Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity
Not yet recruiting NCT06375265 - Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients N/A
Recruiting NCT05572307 - Peripheral Blood Single Cell Sequencing Analysis of POD and CPSP in Elderly Patients After Total Knee Arthroplasty
Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
Not yet recruiting NCT05537155 - Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery N/A
Completed NCT01964274 - Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
Completed NCT01599689 - Pilot and Feasibility Study of a Mirrors Intervention for Reducing Delirium in Older Cardiac Surgical Patients N/A
Active, not recruiting NCT03291626 - Postoperative Delirium: EEG Markers of Sleep and Wakefulness
Completed NCT04312516 - Greek Validation of ACE III Test in Perioperative Patients