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

NCT07588178 | Recruiting

• 1 other identifier: 2025-2877
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Problems; Delirium - Postoperative

Outcome Measures

Primary Outcomes (1)

• Differential changes in plasma metabolic substances during the perioperative period

  24 hours before and after the operation

Secondary Outcomes (4)

• 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

Study Arms (1)

Adult patients scheduled for elective cardiac surgery

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

Interventions

This is a observational study and there is no intervention. OTHER

This is a observational study and there is no intervention.

Adult patients scheduled for elective cardiac surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients scheduled for elective cardiac surgery

You may qualify if:

• Age ≥ 18 years
• Scheduled for elective cardiac surgery

You may not qualify if:

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

Sponsors & Collaborators

• Yan Fuxia: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, fecal sample

MeSH Terms

Conditions

Emergence Delirium; Parasomnias

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders

Central Study Contacts

Fuxia Yan, MD

CONTACT

01088396628; yanfuxia@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chinese Academy of Medical Sciences, Fuwai Hospital

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

CN (1)