- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259850
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
Status
Completed
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
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- 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 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:
- Aged ≥65 years;
- Scheduled for elective non-cardiac, non-neurosurgical procedures;
- Consented to undergo preoperative health and functional state assessments.
Exclusion criteria:
- 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.
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 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.
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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 worsened frailty at one month after surgery.
Time Frame: At one month after surgery.
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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.
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At one month after surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The secondary outcome was 1-year all-cause mortality.
Time Frame: At one year after surgery.
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A structured telephone follow-up was conducted one year after surgery to determine outcomes.
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At one year after surgery.
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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)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGH - FRAIL
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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