Postoperative DeliriumPhase 4NCT06178835
EPO for Postop Delirium in Elderly Patients
A Phase 4 study testing Erythropoietin and normal saline in people with Postoperative Delirium, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Erythropoietin and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Sep 2017to 28 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years and older
- Patients scheduled for elective total knee arthroplasty, total hip arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea
Seoul
About this study
Official title: 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.
- Conditions
- Postoperative Delirium
- Being tested
- Erythropoietin, normal saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Experimental | 500 IU/kg of EPO given intramuscularly 3 times for each patient Receives: Drug: Erythropoietin |
| Control | Placebo comparator | Same amount of normal saline given intramuscularly 3 times for each patient Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
Development of postoperative delirium determined by validated evaluation tests.
Measured: 2 days post surgery, 5 days post surgery
Secondary outcomes (1)
Inflammatory biomarker
Preoperative and postoperative comparison of inflammatory biomarkers (IL-1, IL-6, TNF-a)
Measured: before surgery, after surgery, 3 days post surgery day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start12 Sep 2017
- Primary completion28 Jul 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bon-Nyeo Koo, Principal investigator, Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178835
- Sponsor's protocol ID
- 4-2017-0694
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39548414
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythropoietin for the Prevention of Postoperative Delirium in Elderly Patients Undergoing Total Joint Arthroplasty: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06178835
- Acronym / sponsor ID
- 4-2017-0694
- Conditions
- Postoperative Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 28 Jul 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | Experimental | Drug: Erythropoietin500 IU/kg of EPO given intramuscularly 3 times for each patient |
| Control | Placebo comparator | Drug: normal salineSame amount of normal saline given intramuscularly 3 times for each patient |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years and older
- Patients scheduled for elective total knee arthroplasty, total hip arthroplasty
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythropoietin500 IU/kg of erythropoietin is given 3 times for each patient: the day before surgery, start of surgery and on postoperative day 1. | Drug | Erythropoietin |
| normal salineThe same amount of normal saline is given 3 times for each patient: the day before surgery, start of surgery and on postoperative day 1. | Drug | Control |
Primary outcome
Incidence of delirium
Time frame: 2 days post surgery, 5 days post surgery
Development of postoperative delirium determined by validated evaluation tests.
1 secondary outcome
Inflammatory biomarker
Time frame: before surgery, after surgery, 3 days post surgery day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Derived from this study: PubMed 39548414Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon-Nyeo Koo principal investigator
Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythropoietin and normal saline in people with Postoperative Delirium, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: 2 days post surgery, 5 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06178835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023; AzTrials last refreshed its copy on 1 Nov 2026.