Postoperative Delirium (POD)NCT07259850
Associations of Postoperative Delirium With Perioperative Frailty Worsening and Their Combined Effect on 1-Year Mortality in Older Surgical Patients
An observational study of Postoperative Delirium (POD) and Frailty at Older Adults, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Postoperative delirium (POD) is a frequent complication in older surgical patients and is associated with adverse outcomes, while frailty is also highly prevalent during the perioperative period. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Frailty at Older Adults, Mortality
- How many people
- 6,196 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Apr 2023
- 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
- No healthy volunteers
- Older adult
Study population: Patients were divided into postoperative delirium (POD) and non-POD groups based on delirium occurrence within 7 days after surgery. Follow-up assessments were conducted at 30 days and 1 year postoperatively to evaluate frailty change and survival outcomes.
Who may be able to join
- Aged ≥65 years;
- Scheduled for elective non-cardiac, non-neurosurgical procedures;
- Consented to undergo preoperative health and functional state assessments.
Who cannot join
- Had severe dementia, language disorders, significant hearing or visual impairments, or were in a coma;
- Had Mini-Mental State Examination (MMSE) scores below the established educational thresholds: <18 for illiterate individuals, <21 for those with primary education (≤6 years), and <25 for those with secondary education or higher (>6 years)
- Underwent local anesthesia or monitored anesthesia care;
- Had an operative time ≤30 minutes;
- Incomplete preoperative FRAIL scale assessment;
- Missing postoperative delirium data;
- Incomplete FRAIL scale assessment at 1 month postoperatively.
Trial locations and contacts
1 site in 1 country.
China1 site
28 Fuxing Road, Haidian District
Beijing, Beijing Municipality, 100853
About this study
Official title: Associations of Postoperative Delirium With Perioperative Frailty Worsening and Their Combined Effect on 1-Year Mortality in Older Surgical Patients: A Prospective Cohort Study
Postoperative delirium (POD) is a frequent complication in older surgical patients and is associated with adverse outcomes, while frailty is also highly prevalent during the perioperative period. This study aimed to determine whether POD accelerates perioperative frailty worsening and to assess the effect of their coexistence on 1-year mortality.
- Keywords
- postoperative delirium, frailty, older adults, one year mortality, frailty worsening
- Medical subject headings
- Emergence Delirium, Frailty
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 |
|---|---|---|
| A retrospective cohort study based on prospectively collected data. | Patients were classified into POD and non-POD groups according to the occurrence of delirium within 7 days after surgery. The study examined the association between POD and worsened frailty at 1 month, and their combined effect on 1-year mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was worsened frailty at one month after surgery.
Frailty was assessed preoperatively by trained researchers using the FRAIL scale, which includes five items: fatigue, resistance, ambulation, illnesses, and weight loss. Each item scores 0 or 1, for a total of 0-5 points, with higher scores indicating greater frailty. Patients were categorized as robust (0), pre-frail (1-2), or frail (3-5). A follow-up frailty assessment was conducted one month postoperatively via telephone. Frailty change was defined as the difference between postoperative and preoperative scores: ≤0 indicated stable/improved frailty, and >0 indicated worsened frailty.
Measured: At one month after surgery.
Secondary outcomes (1)
The secondary outcome was 1-year all-cause mortality.
A structured telephone follow-up was conducted one year after surgery to determine outcomes.
Measured: At one year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259850
- Sponsor's protocol ID
- PLAGH - FRAIL
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Postoperative Delirium With Perioperative Frailty Worsening and Their Combined Effect on 1-Year Mortality in Older Surgical Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07259850
- Acronym / sponsor ID
- PLAGH - FRAIL
- Keywords
- postoperative delirium, frailty, older adults, one year mortality, frailty worsening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,196 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Dec 2025 (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 (POD) is a frequent complication in older surgical patients and is associated with adverse outcomes, while frailty is also highly prevalent during the perioperative period. This study aimed to determine whether POD accelerates perioperative frailty worsening and to assess the effect of their coexistence on 1-year mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A retrospective cohort study based on prospectively collected data. | – | –Patients were classified into POD and non-POD groups according to the occurrence of delirium within 7 days after surgery. The study examined the association between POD and worsened frailty at 1 month, and their combined effect on 1-year mortality. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients were divided into postoperative delirium (POD) and non-POD groups based on delirium occurrence within 7 days after surgery. Follow-up assessments were conducted at 30 days and 1 year postoperatively to evaluate frailty change and survival outcomes.
Key inclusion criteria (3 listed)
- Aged ≥65 years;
- Scheduled for elective non-cardiac, non-neurosurgical procedures;
- Consented to undergo preoperative health and functional state assessments.
Key exclusion criteria (7 listed)
- Had severe dementia, language disorders, significant hearing or visual impairments, or were in a coma;
- Had Mini-Mental State Examination (MMSE) scores below the established educational thresholds: <18 for illiterate individuals, <21 for those with primary education (≤6 years), and <25 for those with secondary education or higher (>6 years)
- Underwent local anesthesia or monitored anesthesia care;
- Had an operative time ≤30 minutes;
- Incomplete preoperative FRAIL scale assessment;
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 primary outcome was worsened frailty at one month after surgery.
Time frame: At one month after surgery.
Frailty was assessed preoperatively by trained researchers using the FRAIL scale, which includes five items: fatigue, resistance, ambulation, illnesses, and weight loss. Each item scores 0 or 1, for a total of 0-5 points, with higher scores indicating greater frailty. Patients were categorized as robust (0), pre-frail (1-2), or frail (3-5). A follow-up frailty assessment was conducted one month postoperatively via telephone. Frailty change was defined as the difference between postoperative and preoperative scores: ≤0 indicated stable/improved frailty, and >0 indicated worsened frailty.
1 secondary outcome
The secondary outcome was 1-year all-cause mortality.
Time frame: At one year after surgery.
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 9 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (POD) and Frailty at Older Adults, run by Chinese PLA General 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 3 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 9 Dec 2025. 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 primary outcome was worsened frailty at one month after surgery. (time frame: At one month after surgery.). 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 9 Dec 2025.