- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07322744
Preoperative Lymphocyte-to-Monocyte Ratio and Postoperative Delirium by Frailty Status in Older Surgical Patients
January 8, 2026 updated by: Yanhong Liu, Chinese PLA General Hospital
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
6475
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- 28 Fuxing Road, Haidian District
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Aged ≥65 years;
- Underwent elective noncardiac, nonneurosurgical procedures;
- Completed the preoperative health and functional status questionnaire.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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The primary outcome was the occurrence of POD, evaluated by trained researchers using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).
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POD assessment was performed twice daily for up to seven consecutive postoperative days or until hospital discharge, whichever occurred first.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
December 23, 2025
First Submitted That Met QC Criteria
December 23, 2025
First Posted (Estimated)
January 7, 2026
Study Record Updates
Last Update Posted (Actual)
January 9, 2026
Last Update Submitted That Met QC Criteria
January 8, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMR - POD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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