ClinicalTrials.gg
Not yet recruitingNCT07900009Updated Oct 28, 2026

Biomarkers of Postoperative Complications After Cardiac Surgery

An observational study in Postoperative Complications, sponsored by Rao Sun. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Rao Sun · Observational

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Postoperative Complications
03

In context

Postoperative Complications

1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.

This study's planned enrollment of 300 is above the median of 251 across 537 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Rao Sun is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients undergoing elective coronary artery bypass grafting, cardiac valve surgery, or combined procedures at Tongji hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 obtained from the participant or, where permitted, a legally authorized representative.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Otherno intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: From surgery through postoperative day 7 or hospital discharge, whichever occurs first.

Secondary outcomes

  1. Incidence of postoperative acute kidney injury

    Time frame: Within 7 days after surgery

  2. Incidence of postoperative pneumonia

    Time frame: Within 30 days after surgery

  3. Incidence of new-onset postoperative atrial fibrillation

    Time frame: Within 30 days after surgery

  4. Incidence of postoperative stroke

    Time frame: Within 30 days after surgery

  5. Incidence of postoperative sepsis

    Time frame: Within 30 days after surgery

  6. Duration of postoperative mechanical ventilation

    Time frame: Within 30 days after surgery

  7. Length of ICU stay

    Time frame: Within 30 days after surgery

  8. Length of postoperative hospital stay

    Time frame: Within 30 days after surgery

  9. 30-day all-cause mortality

    Time frame: 30 days after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07900009
Lead sponsor
Rao Sun
Responsible party
Rao Sun (Associate chief physician, Tongji Hospital) — Sponsor-investigator
First posted
Oct 28, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Rao Sun
Contact
raosun@hust.edu.cn
+86-27-83663173
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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