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NCT Number: NCT07588178

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Fuxia Yan, MD

CONTACT

[email protected]

01088396628

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

This is a observational study and there is no intervention.

Other

This is a observational study and there is no intervention.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fuxia Yan, MD

CONTACT

[email protected]

01088396628

Sponsors and collaborators

Lead sponsor

Yan Fuxia

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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