Delirium - PostoperativeNCT07588178
Metabolomics and Biomarker Research on the Mechanism of Preoperative Sleep Disorders Affecting Postoperative Outcomes in Cardiac Surgery Patients
An observational study of Delirium - Postoperative and Sleep Problems, run by Yan Fuxia at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Delirium - Postoperative, Sleep Problems
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective cardiac surgery
Who may be able to join
- Age ≥ 18 years
- Scheduled for elective cardiac surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Fuxia Yan, MD, 01088396628, yanfuxia@sina.com
About this study
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
- Delirium - Postoperative, Sleep Problems
- Being tested
- This is a observational study and there is no intervention.
- Medical subject headings
- Emergence Delirium, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a observational study and there is no intervention.Other
This is a observational study and there is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients scheduled for elective cardiac surgery | Not described Receives: Other: This is a observational study and there is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential changes in plasma metabolic substances during the perioperative period
Measured: 24 hours before and after the operation
Secondary outcomes (4)
Perioperative inflammatory marker levels
Measured: 24 hours before and after the surgery
Perioperative nerve injury marker levels
Measured: 24 hours before and after the surgery
Perioperative oxidative stress marker levels
Measured: 24 hours before and after the surgery
Characteristics of the intestinal flora before the surgery
Measured: 24 hours before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Fuxia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Fuxia, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588178
- Sponsor's protocol ID
- 2025-2877
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics and Biomarker Research on the Mechanism of Preoperative Sleep Disorders Affecting Postoperative Outcomes in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT07588178
- Acronym / sponsor ID
- 2025-2877
- Conditions
- Delirium - Postoperative, Sleep Problems
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Yan FuxiaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients scheduled for elective cardiac surgery | – | Other: This is a observational study and there is no intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective cardiac surgery
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Scheduled for elective cardiac surgery
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a observational study and there is no intervention.This is a observational study and there is no intervention. | Other | Adult patients scheduled for elective cardiac surgery |
Primary outcome
Differential changes in plasma metabolic substances during the perioperative period
Time frame: 24 hours before and after the operation
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium - Postoperative and Sleep Problems, run by Yan Fuxia at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuxia Yan, MD (01088396628, yanfuxia@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential changes in plasma metabolic substances during the perioperative period (time frame: 24 hours before and after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.