Postoperative DeliriumNCT03130231
Predictive Value of β2-microspheres for Postoperative Delirium
An observational study of Postoperative Delirium, run by Zhongda Hospital at 1 site in China.
Trial summary
This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD) in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in plasma and cerebrospinal fluid were compared between the POD and non-POD groups. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2015to 30 Dec 2017
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Older adult
Study population: Patients aged ≥65 years undergoing orthopedic operations under spinal anesthesia were investigated.
Who may be able to join
- ≥65 years old, American Standards AssociationⅠ-Ⅲ, undergoing orthopedic operations under spinal anesthesia
Who cannot join
- decline to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Predictive Value of β2-microspheres for Postoperative Delirium in the Elderly After Orthopedic Surgery
This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD) in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in plasma and cerebrospinal fluid were compared between the POD and non-POD groups.
Read the detailed description
In this study, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres before operation. Also, the patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups. The aim of the present study was to assess whether higher levels of β2-microspheres could predict the occurrence of POD.
- Conditions
- Postoperative Delirium
- Keywords
- Delirium β2-microspheres
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| POD group | POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method. | |
| Non-POD group | Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of POD
The patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups.
Measured: 4 days
Secondary outcomes (1)
The levels of β2-microspheres in plasma and cerebrospinal fluid
Before surgery, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Oct 2015
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-jun Yang, Zhongda Hospital
- Investigators
- Jian-jun Yang, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130231
- Sponsor's protocol ID
- 199101026046
- Status last verified
- Dec 2018
- First submitted
- 15 Apr 2017
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of β2-microspheres for Postoperative Delirium in the Elderly After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT03130231
- Acronym / sponsor ID
- 199101026046
- Conditions
- Postoperative Delirium
- Keywords
- Delirium β2-microspheres
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 26 Apr 2017 (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.
This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD) in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in plasma and cerebrospinal fluid were compared between the POD and non-POD groups.
Detailed description
In this study, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres before operation. Also, the patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups. The aim of the present study was to assess whether higher levels of β2-microspheres could predict the occurrence of POD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POD group | – | –POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method. |
| Non-POD group | – | –Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients aged ≥65 years undergoing orthopedic operations under spinal anesthesia were investigated.
Key inclusion criteria (1 listed)
- ≥65 years old, American Standards AssociationⅠ-Ⅲ, undergoing orthopedic operations under spinal anesthesia
Key exclusion criteria (1 listed)
- decline to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of POD
Time frame: 4 days
The patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups.
1 secondary outcome
The levels of β2-microspheres in plasma and cerebrospinal fluid
Time frame: 1 day
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 27 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Postoperative Delirium
Not yet recruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
Not yet recruiting
Intranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy
Emergence Agitation, Vocal Cord Polyps
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
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.
Jian-jun Yang principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Zhongda Hospital at 1 site in China.
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 1 inclusion and 1 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 27 Dec 2018. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The incidence of POD (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2018.