NCT07194096

Brief Summary

Postoperative delirium is a common and serious complication associated with prolonged hospitalization, increased morbidity and mortality, and elevated healthcare costs. Identifying reliable predictive biomarkers for early risk stratification is crucial for implementing preventive strategies and improving patient outcomes. The stress hyperglycemia ratio (SHR) is an emerging biomarker that quantifies stress-induced hyperglycemia relative to baseline glycemic status, providing an assessment of physiological stress. This metric has been associated with various adverse outcomes. Given that surgical stress triggers neuroendocrine and inflammatory responses potentially contributing to delirium pathogenesis, SHR may indicate vulnerability to postoperative cognitive dysfunction. The primary objective of this retrospective study is to investigate the association between preoperative stress hyperglycemia ratio and postoperative delirium development. Additionally, we aim to evaluate the predictive value of preoperative SHR for postoperative delirium risk stratification. This investigation may provide insights into metabolic stress-related mechanisms underlying postoperative cognitive outcomes and identify a clinically applicable biomarker for delirium risk assessment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 5, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

September 5, 2025

Last Update Submit

September 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with postoperative delirium

    Perioperative/Periprocedural

Interventions

no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18 years or older who underwent non-neurosurgical and non-cardiac surgical procedures at Tongji Hospital between 2014 and 2024 were included.

You may qualify if:

  • Adults aged ≥18 years
  • Underwent non-neurosurgical and non-cardiac surgical procedures
  • For patients with multiple qualifying surgical procedures during the study period, only data from the first eligible surgery were analyzed

You may not qualify if:

  • American Society of Anesthesiologists (ASA) physical status V
  • Procedural sedation or anesthesia performed outside the operating room, or total anesthesia duration ≤60 minutes
  • Preoperative delirium or dementia
  • Insufficient laboratory data for calculating the stress hyperglycemia ratio (SHR)
  • Missing values for essential confounding variables required for multivariable analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rao Sun

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 26, 2025

Study Start

October 15, 2025

Primary Completion

November 15, 2025

Study Completion

November 20, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share