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

NCT07259850 | Completed

• 1 other identifier: PLAGH - FRAIL
• Study Type: observational
• Target: 6,196
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium (POD); Frailty at Older Adults; Mortality; Recovery of Function

Keywords

postoperative delirium; frailty; older adults; one year mortality; frailty worsening

Outcome Measures

Primary Outcomes (1)

• The primary outcome was worsened frailty 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 Outcomes (1)

• The secondary outcome was 1-year all-cause mortality.

  At one year after surgery.

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

28 Fuxing Road, Haidian District

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Emergence Delirium; Frailty

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental 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: November 21, 2025
• First Posted: December 2, 2025
• Study Start: April 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2023
• Last Updated: December 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)