Postoperative DeliriumNCT07194096
Stress Hyperglycemia Ratio and Postoperative Delirium
An observational study of Postoperative Delirium, run by Rao Sun.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 20 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preoperative Stress Hyperglycemia Ratio and Postoperative Delirium
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.
- Conditions
- Postoperative Delirium
- Being tested
- no intervention
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative delirium
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rao Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rao Sun, Tongji Hospital
- Investigators
- Rao Sun, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194096
- Sponsor's protocol ID
- TJ-IRB202509010A
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Stress Hyperglycemia Ratio and Postoperative Delirium
- ClinicalTrials.gov ID
- NCT07194096
- Acronym / sponsor ID
- TJ-IRB202509010A
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Rao SunUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Number of participants with postoperative delirium
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rao Sun principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Rao Sun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rao Sun (+86-27-83663173, raosun@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative delirium (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.