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RecruitingNCT07588178Updated May 14, 2026

Metabolomics and Biomarker Research on the Mechanism of Preoperative Sleep Disorders Affecting Postoperative Outcomes in Cardiac Surgery Patients

An observational study in Delirium - Postoperative and Sleep Problems, sponsored by Yan Fuxia. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Yan Fuxia · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
144
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study is titled "Metabolomics and Biomarker Research on the Mechanism of Preoperative Sleep Disorders Affecting Postoperative Outcomes in Adult Cardiac Surgery". It aims to clarify the perioperative metabolic changes caused by preoperative sleep disorders in adult cardiac surgery patients, providing ideas for exploring the mechanism by which sleep disorders affect adverse outcomes after cardiac surgery. The study will be conducted at Fuwai Hospital, Chinese Academy of Medical Sciences. By collecting perioperative blood and fecal samples from adult cardiac surgery patients with and without preoperative sleep disorders, and simultaneously recording postoperative clinical outcome indicators (such as the incidence of delirium within 7 days after surgery, cognitive function scores, mechanical ventilation time, ICU stay time, hospital stay time, and severe cardiovascular adverse events), the study will explore the impact of preoperative sleep disorders on perioperative plasma metabolic substances, inflammatory levels, nerve damage, oxidative stress levels, and intestinal flora in adult cardiac surgery patients under general anesthesia, providing ideas and evidence for exploring the mechanism by which preoperative sleep disorders affect postoperative outcomes in adult cardiac surgery patients under general anesthesia.

02

Conditions studied

  • Delirium - Postoperative
  • Sleep Problems
03

In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's planned enrollment of 144 is below the median of 164 across 280 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Yan Fuxia is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients scheduled for elective cardiac surgery

Inclusion criteria

  1. Age ≥ 18 years
  2. Scheduled for elective cardiac surgery

Exclusion criteria

Exclusion Criteria:

  1. Has a history of neurosurgery, or has suffered from neurological diseases such as cerebral hemorrhage, cerebral infarction, delirium, dementia, etc.
  2. Has a history of mental disorders.
  3. Heavy alcohol consumption.
  4. American Society of Anesthesiologists (ASA) classification level IV or above.
  5. Complicated with severe liver dysfunction (Child-Pugh C grade) or renal dysfunction (chronic kidney disease stage 3-4).
  6. Unable to communicate due to hearing or language problems, or refuses to sign the informed consent form.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
144 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Adult patients scheduled for elective cardiac surgery

    Other: This is a observational study and there is no intervention.

Interventions

  • OtherThis is a observational study and there is no intervention.

    This is a observational study and there is no intervention.

06

What researchers measure

Primary outcomes

  1. Differential changes in plasma metabolic substances during the perioperative period

    Time frame: 24 hours before and after the operation

Secondary outcomes

  1. Perioperative inflammatory marker levels

    Time frame: 24 hours before and after the surgery

  2. Perioperative nerve injury marker levels

    Time frame: 24 hours before and after the surgery

  3. Perioperative oxidative stress marker levels

    Time frame: 24 hours before and after the surgery

  4. Characteristics of the intestinal flora before the surgery

    Time frame: 24 hours before the surgery

07

Study locations

1 of 1 sites recruiting
  • Fuwai Hospital
    Beijing, Beijing Municipality 100037, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07588178
Lead sponsor
Yan Fuxia
Responsible party
Yan Fuxia (Chinese Academy of Medical Sciences, Fuwai Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital) — Sponsor-investigator
First posted
May 14, 2026
Start date
Jan 1, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 14, 2026

Study contacts

Fuxia Yan, MD
Contact
yanfuxia@sina.com
01088396628

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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