Metabolomics and Biomarker Research on the Mechanism of Preoperative Sleep Disorders Affecting Postoperative Outcomes in Cardiac Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: This is a observational study and there is no intervention..
- Who it may be relevant to
- Registry conditions: Delirium - Postoperative, Sleep Problems. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other This is a observational study and there is no intervention.
This is a observational study and there is no intervention.
Primary outcome measures
- Differential changes in plasma metabolic substances during the perioperative period [Time frame: 24 hours before and after the operation]
Secondary outcome measures (4)
- Perioperative inflammatory marker levels [Time frame: 24 hours before and after the surgery]
- Perioperative nerve injury marker levels [Time frame: 24 hours before and after the surgery]
- Perioperative oxidative stress marker levels [Time frame: 24 hours before and after the surgery]
- Characteristics of the intestinal flora before the surgery [Time frame: 24 hours before the surgery]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Scheduled for elective cardiac surgery
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fuwai Hospital — Beijing
Identifiers
NCT: NCT07588178 · 2025-2877