Associations of Postoperative Delirium With Perioperative Frailty Worsening and Their Combined Effect on 1-Year Mortality in Older Surgical Patients

December 7, 2025 updated by: Yanhong Liu, Chinese PLA General Hospital

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

6196

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

    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • 28 Fuxing Road, Haidian District

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 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.

Description

Inclusion criteria:

  1. Aged ≥65 years;
  2. Scheduled for elective non-cardiac, non-neurosurgical procedures;
  3. Consented to undergo preoperative health and functional state assessments.

Exclusion criteria:

  1. Had severe dementia, language disorders, significant hearing or visual impairments, or were in a coma;
  2. 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)
  3. Underwent local anesthesia or monitored anesthesia care;
  4. Had an operative time ≤30 minutes;
  5. Incomplete preoperative FRAIL scale assessment;
  6. Missing postoperative delirium data;
  7. Incomplete FRAIL scale assessment at 1 month postoperatively.

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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At one month after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome was 1-year all-cause mortality.
Time Frame: At one year after surgery.
A structured telephone follow-up was conducted one year after surgery to determine outcomes.
At one year after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

April 30, 2023

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Estimated)

December 2, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

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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