Postoperative Delirium (POD)NCT07322744
Preoperative Lymphocyte-to-Monocyte Ratio and Postoperative Delirium by Frailty Status 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
Both frailty and a reduced preoperative lymphocyte-to-monocyte ratio (LMR) are known risk factors for postoperative delirium (POD). However, whether the relationship between LMR and POD varies by frailty status remains unclear. 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, Lymphocyte
- How many people
- 6,475 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Dec 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 grouped according to the preoperative lymphocyte-to-monocyte ratio (LMR) and were further stratified into subgroups based on frailty status, which was assessed one day before surgery using the FRAIL scale. Postoperative delirium was assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) for seven consecutive postoperative days or until hospital discharge, whichever occurred first.
Who may be able to join
- Aged ≥65 years;
- Underwent elective noncardiac, nonneurosurgical procedures;
- Completed the preoperative health and functional status questionnaire.
Who cannot join
- Severe dementia, language disorders, significant hearing or visual impairments, or coma;
- Cognitive function below the Mini-Mental State Examination thresholds (<18 for illiterate individuals, <21 for individuals with primary education, and <25 for individuals with secondary education or higher);
- Surgery performed under local anesthesia or monitored anesthesia care;
- Missing lymphocyte or monocyte count data;
- Missing postoperative delirium assessment;
- Incomplete preoperative FRAIL scale evaluation;
- Missing data for more than 20% of covariates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Preoperative Lymphocyte-to-Monocyte Ratio and Postoperative Delirium According to Frailty Status in Older Surgical Patients: A Prospective Cohort Study
Both frailty and a reduced preoperative lymphocyte-to-monocyte ratio (LMR) are known risk factors for postoperative delirium (POD). However, whether the relationship between LMR and POD varies by frailty status remains unclear. This study aimed to evaluate the frailty-stratified association between preoperative LMR and POD in older surgical patients.
- Keywords
- postoperative delirium, frailty, older surgical patients, lymphocyte-to-monocyte ratio
- 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 grouped according to the preoperative lymphocyte-to-monocyte ratio (LMR), calculated as the lymphocyte count divided by the monocyte count. Lymphocyte and monocyte values were obtained from the most recent preoperative laboratory test. Frailty was assessed one day before surgery using the FRAIL scale, which comprises five domains: fatigue, resistance, ambulation, illnesses, and weight loss. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 5, with higher scores indicating greater frailty. Based on the total score, patients were categorized as robust (0 points), pre-frail (1-2 points), or frail (3-5 points). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the occurrence of postoperative delirium (POD).
The primary outcome was the occurrence of POD, evaluated by trained researchers using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).
Measured: POD assessment was performed twice daily for up to seven consecutive postoperative days or until hospital discharge, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 Dec 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
- 6,475 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
- NCT07322744
- Sponsor's protocol ID
- LMR - POD
- Status last verified
- Nov 2025
- First submitted
- 23 Dec 2025
- Last updated
- 9 Jan 2026
- 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Lymphocyte-to-Monocyte Ratio and Postoperative Delirium According to Frailty Status in Older Surgical Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07322744
- Acronym / sponsor ID
- LMR - POD
- Keywords
- postoperative delirium, frailty, older surgical patients, lymphocyte-to-monocyte ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,475 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 Dec 2023 (actual)
- First posted
- 7 Jan 2026 (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.
Both frailty and a reduced preoperative lymphocyte-to-monocyte ratio (LMR) are known risk factors for postoperative delirium (POD). However, whether the relationship between LMR and POD varies by frailty status remains unclear. This study aimed to evaluate the frailty-stratified association between preoperative LMR and POD in older surgical patients.
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 grouped according to the preoperative lymphocyte-to-monocyte ratio (LMR), calculated as the lymphocyte count divided by the monocyte count. Lymphocyte and monocyte values were obtained from the most recent preoperative laboratory test. Frailty was assessed one day before surgery using the FRAIL scale, which comprises five domains: fatigue, resistance, ambulation, illnesses, and weight loss. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 5, with higher scores indicating greater frailty. Based on the total score, patients were categorized as robust (0 points), pre-frail (1-2 points), or frail (3-5 points). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients were grouped according to the preoperative lymphocyte-to-monocyte ratio (LMR) and were further stratified into subgroups based on frailty status, which was assessed one day before surgery using the FRAIL scale. Postoperative delirium was assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) for seven consecutive postoperative days or until hospital discharge, whichever occurred first.
Key inclusion criteria (3 listed)
- Aged ≥65 years;
- Underwent elective noncardiac, nonneurosurgical procedures;
- Completed the preoperative health and functional status questionnaire.
Key exclusion criteria (7 listed)
- Severe dementia, language disorders, significant hearing or visual impairments, or coma;
- Cognitive function below the Mini-Mental State Examination thresholds (<18 for illiterate individuals, <21 for individuals with primary education, and <25 for individuals with secondary education or higher);
- Surgery performed under local anesthesia or monitored anesthesia care;
- Missing lymphocyte or monocyte count data;
- Missing postoperative delirium 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 the occurrence of postoperative delirium (POD).
Time frame: POD assessment was performed twice daily for up to seven consecutive postoperative days or until hospital discharge, whichever occurred first.
The primary outcome was the occurrence of POD, evaluated by trained researchers using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).
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 Jan 2026.
- 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 Jan 2026. 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 the occurrence of postoperative delirium (POD). (time frame: POD assessment was performed twice daily for up to seven consecutive postoperative days or until hospital discharge, whichever occurred first.). 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 Jan 2026.