Postoperative ComplicationsNCT07900009
Biomarkers of Postoperative Complications After Cardiac Surgery
An observational study of Postoperative Complications, run by Rao Sun.
Trial summary
Postoperative delirium and other complications are important adverse outcomes following cardiac surgery. This study will integrate perioperative clinical information with molecular measurements to investigate factors associated with these outcomes and improve early risk assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Jul 2027
- 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 undergoing elective coronary artery bypass grafting, cardiac valve surgery, or combined procedures at Tongji hospital.
Who may be able to join
- Age ≥18 years.
- Scheduled for elective coronary artery bypass grafting, cardiac valve surgery, or combined procedures at the study center.
- Planned postoperative admission to the ICU.
- Written informed consent obtained from the participant or, where permitted, a legally authorized representative.
Who cannot join
- Preoperative delirium.
- Severe preoperative hearing, visual, or communication impairment that prevents reliable delirium assessment.
- Severe pre-existing dementia, active severe psychiatric illness, or other neuropsychiatric conditions that preclude reliable delirium assessment.
- Emergency surgery.
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: Biomarkers and Risk Prediction for Postoperative Delirium and Other Complications After Cardiac Surgery
Postoperative delirium and other complications are important adverse outcomes following cardiac surgery. This study will integrate perioperative clinical information with molecular measurements to investigate factors associated with these outcomes and improve early risk assessment.
Eligible patients undergoing elective coronary artery bypass grafting, cardiac valve surgery, or combined procedures will be prospectively enrolled. Data collection will include demographic characteristics, medical history, preoperative medications, laboratory findings, surgical and anesthetic characteristics, and postoperative clinical outcomes.
Read more
Blood samples will be collected before surgery and approximately 24 hours after surgery, processed according to standardized procedures, and stored for subsequent analyses. Molecular investigations will include proteomic and metabolomic profiling and targeted measurement of selected biomarkers.
POD will be assessed twice daily by trained research personnel during the first 7 postoperative days or until hospital discharge, whichever occurs first. Standardized, validated delirium assessment instruments will be used in the ICU and after transfer to the ward. Other postoperative complications and recovery outcomes will be recorded prospectively.
Analyses will examine associations between clinical characteristics, molecular profiles, and postoperative outcomes. Causal inference methods will be used, where appropriate, to explore the potential causal relevance of candidate biomarkers under explicitly stated assumptions. Interpretable prediction models will be developed using clinical variables, molecular features, or their combination. Model performance will be assessed in terms of discrimination, calibration, and potential clinical utility. Internal validation will be performed, and temporal or external validation will be undertaken where suitable independent data are available.
- Conditions
- Postoperative Complications
- Being tested
- no intervention
- Medical subject headings
- Postoperative Complications
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.
Incidence of postoperative delirium
Proportion of participants with at least one positive standardized delirium assessment during the observation period. Assessments will be performed twice daily by trained personnel using the CAM-ICU/CAM .
Measured: From surgery through postoperative day 7 or hospital discharge, whichever occurs first.
Secondary outcomes (9)
Incidence of postoperative acute kidney injury
Measured: Within 7 days after surgery
Incidence of postoperative pneumonia
Measured: Within 30 days after surgery
Incidence of new-onset postoperative atrial fibrillation
Measured: Within 30 days after surgery
Incidence of postoperative stroke
Measured: Within 30 days after surgery
Incidence of postoperative sepsis
Measured: Within 30 days after surgery
Duration of postoperative mechanical ventilation
Measured: Within 30 days after surgery
Length of ICU stay
Measured: Within 30 days after surgery
Length of postoperative hospital stay
Measured: Within 30 days after surgery
30-day all-cause mortality
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rao Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rao Sun, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900009
- Sponsor's protocol ID
- TJ-IRB202604113A
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Risk Prediction for Postoperative Delirium and Other Complications After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07900009
- Acronym / sponsor ID
- TJ-IRB202604113A
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rao SunUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 28 Oct 2026 (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 and other complications are important adverse outcomes following cardiac surgery. This study will integrate perioperative clinical information with molecular measurements to investigate factors associated with these outcomes and improve early risk assessment.
Eligible patients undergoing elective coronary artery bypass grafting, cardiac valve surgery, or combined procedures will be prospectively enrolled. Data collection will include demographic characteristics, medical history, preoperative medications, laboratory findings, surgical and anesthetic characteristics, and postoperative clinical outcomes.
Blood samples will be collected before surgery and approximately 24 hours after surgery, processed according to standardized procedures, and stored for subsequent analyses. Molecular investigations will include proteomic and metabolomic profiling and targeted measurement of selected biomarkers.
POD will be assessed twice daily by trained research personnel during the first 7 postoperative days or until hospital discharge, whichever occurs first. Standardized, validated delirium assessment instruments will be used in the ICU and after transfer to the ward. Other postoperative complications and recovery outcomes will be recorded prospectively.
Analyses will examine associations between clinical characteristics, molecular profiles, and postoperative outcomes. Causal inference methods will be used, where appropriate, to explore the potential causal relevance of candidate biomarkers under explicitly stated assumptions. Interpretable prediction models will be developed using clinical variables, molecular features, or their combination. Model performance will be assessed in terms of discrimination, calibration, and potential clinical utility. Internal validation will be performed, and temporal or external validation will be undertaken where suitable independent data are available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective coronary artery bypass grafting, cardiac valve surgery, or combined procedures at Tongji hospital.
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Scheduled for elective coronary artery bypass grafting, cardiac valve surgery, or combined procedures at the study center.
- Planned postoperative admission to the ICU.
- Written informed consent obtained from the participant or, where permitted, a legally authorized representative.
Key exclusion criteria (4 listed)
- Preoperative delirium.
- Severe preoperative hearing, visual, or communication impairment that prevents reliable delirium assessment.
- Severe pre-existing dementia, active severe psychiatric illness, or other neuropsychiatric conditions that preclude reliable delirium assessment.
- Emergency surgery.
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
Incidence of postoperative delirium
Time frame: From surgery through postoperative day 7 or hospital discharge, whichever occurs first.
Proportion of participants with at least one positive standardized delirium assessment during the observation period. Assessments will be performed twice daily by trained personnel using the CAM-ICU/CAM .
9 secondary outcomes
Incidence of postoperative acute kidney injury
Time frame: Within 7 days after surgery
Incidence of postoperative pneumonia
Time frame: Within 30 days after surgery
Incidence of new-onset postoperative atrial fibrillation
Time frame: Within 30 days after surgery
Incidence of postoperative stroke
Time frame: Within 30 days after surgery
Incidence of postoperative sepsis
Time frame: Within 30 days after surgery
Duration of postoperative mechanical ventilation
Time frame: Within 30 days after surgery
Length of ICU stay
Time frame: Within 30 days after surgery
Length of postoperative hospital stay
Time frame: Within 30 days after surgery
30-day all-cause mortality
Time frame: 30 days after surgery
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, 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 4 inclusion and 4 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 28 Oct 2026. 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?
Incidence of postoperative delirium (time frame: From surgery through postoperative day 7 or hospital discharge, whichever occurs first.). 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 28 Oct 2026.