NCT07322744

Brief 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. This study aimed to evaluate the frailty-stratified association between preoperative LMR and POD in older surgical patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

January 9, 2026

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

December 23, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

postoperative deliriumfrailtyolder surgical patientslymphocyte-to-monocyte ratio

Outcome Measures

Primary Outcomes (1)

  • 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).

    POD assessment was performed twice daily for up to seven consecutive postoperative days or until hospital discharge, whichever occurred first.

Study Arms (1)

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).

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Aged ≥65 years;
  • Underwent elective noncardiac, nonneurosurgical procedures;
  • Completed the preoperative health and functional status questionnaire.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

28 Fuxing Road, Haidian District

Beijing, China

Location

MeSH Terms

Conditions

Emergence DeliriumFrailty

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief of administration, Anesthesiology

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 7, 2026

Study Start

April 1, 2020

Primary Completion

April 30, 2022

Study Completion

December 30, 2023

Last Updated

January 9, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations