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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Problems; Delirium - Postoperative
• Intervention / Treatment: Other: This is a observational study and there is no intervention.

• Study Type: Observational
• Enrollment (Estimated): 144

Contacts and Locations

• Study Contact: Name: Fuxia Yan, MD; Phone Number: 01088396628; Email: yanfuxia@sina.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Recruiting
      • Fuwai Hospital
      • Contact: Fuxia Yan, MD; Phone Number: 01088396628; Email: yanfuxia@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients scheduled for elective cardiac surgery

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients scheduled for elective cardiac surgery	Other: This is a observational study and there is no intervention.; This is a observational study and there is no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differential changes in plasma metabolic substances during the perioperative period	24 hours before and after the operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Perioperative inflammatory marker levels	24 hours before and after the surgery
Perioperative nerve injury marker levels	24 hours before and after the surgery
Perioperative oxidative stress marker levels	24 hours before and after the surgery
Characteristics of the intestinal flora before the surgery	24 hours before the surgery

Collaborators and Investigators

• Sponsor: Yan Fuxia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Sleep Wake Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Parasomnias
• Other Study ID Numbers: 2025-2877

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No