Postoperative DeliriumNCT07518992
Correlation Between Preoperative Sleep and Postoperative Brain and Renal Dysfunction
An observational study of Postoperative Delirium and Acute Kidney Injury, run by Xijing Hospital at 1 site in China.
Trial summary
To explore the correlation between preoperative sleep parameter clustering and postoperative brain and renal dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium, Acute Kidney Injury
- How many people
- 549 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults scheduled for elective cardiac surgery with cardiopulmonary bypass
Who may be able to join
- Aged 18 years or above who were scheduled for elective cardiac surgery with cardiopulmonary bypass
Who cannot join
- Patients undergoing congenital heart disease repair surgery or surgeries necessitating deep hypothermic circulatory arrest were excluded.
- Patients with a history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or neurosurgery were also excluded.
- Patients with a preoperative Mini - Mental State Examination (MMSE) score less than 24 , or those unable to communicate due to coma, severe dementia, or language barriers were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Preoperative Sleep Parameters Clustering and Postoperative Brain and Renal Dysfunction
To explore the correlation between preoperative sleep parameter clustering and postoperative brain and renal dysfunction.
Read the detailed description
Postoperative delirium (POD) and acute kidney injury (AKI) are common and serious complications following cardiac surgery. They often occur concurrently and interact with each other, significantly prolonging hospital stay, increasing medical costs, and correlating with long-term cognitive decline, renal function deterioration, and elevated mortality risk. The recently proposed brain-kidney axis theory suggests that the central nervous system and the kidney communicate bidirectionally through pathways including inflammation, oxidative stress, sympathetic overactivation, and hemodynamic instability, amplifying damage in a cascade manner. This provides an important theoretical framework for understanding the comorbidity mechanism of postoperative delirium and renal injury. Early identification of modifiable preoperative risk factors and blocking abnormal activation of the brain-kidney axis are critical to improving outcomes in cardiac surgery patients.
A growing body of evidence indicates that preoperative sleep disturbance is highly prevalent in surgical patients and represents an independent risk factor for adverse perioperative outcomes. Sleep disruption can disrupt circadian rhythms, exacerbate systemic inflammation, impair neurocognitive function, disturb renal hemodynamic homeostasis, and simultaneously aggravate secondary damage to both the central nervous system and the kidney via the brain-kidney axis, thereby significantly increasing the risk of comorbid postoperative delirium and acute kidney injury. However, most previous studies evaluated sleep using a single total scale score or one-dimensional indicators, which cannot fully capture the complexity and heterogeneity of preoperative sleep architecture.
To date, few studies have explored the associations between preoperative sleep phenotypes and postoperative POD, AKI, or their comorbidity in cardiac surgery based on objective sleep monitoring data and combined with the brain-kidney axis theory. Furthermore, the potential mediating role of postoperative sleep disturbance in these pathways remains unclear.
Therefore, this study aims to identify preoperative sleep phenotypes in cardiac surgery patients using cardiopulmonary coupling-derived objective sleep parameters; to investigate the associations of different sleep phenotypes with postoperative POD, AKI, and their comorbidity; and to further conduct subgroup analyses and mediation analyses to explore effect modifiers and underlying mechanisms, with a particular focus on the pathways through which abnormal sleep affects adverse postoperative outcomes via the brain-kidney axis.
- Conditions
- Postoperative Delirium, Acute Kidney Injury
- Medical subject headings
- Emergence Delirium, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative sleep group | The patient underwent cardiopulmonary coupling sleep monitoring one night before operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
assessed with 3-minute confusion assessment method (3D-CAM) or confusion assessment method for the ICU (CAM- ICU)
Measured: within 1 week after operation
Acute kidney injury
assessed with KDIGO criterion
Measured: within 1 week after operation
Postoperative delirium combined with acute kidney injury
both diagnosed as postoperative delirium and acute kidney injury
Measured: within 1 week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start10 Apr 2026
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies 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
- Retrospective
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
- Investigators
- Hailong Dong, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518992
- Sponsor's protocol ID
- KY20222231
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Preoperative Sleep Parameters Clustering and Postoperative Brain and Renal Dysfunction
- ClinicalTrials.gov ID
- NCT07518992
- Acronym / sponsor ID
- KY20222231
- Conditions
- Postoperative Delirium, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 9 Apr 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.
To explore the correlation between preoperative sleep parameter clustering and postoperative brain and renal dysfunction.
Detailed description
Postoperative delirium (POD) and acute kidney injury (AKI) are common and serious complications following cardiac surgery. They often occur concurrently and interact with each other, significantly prolonging hospital stay, increasing medical costs, and correlating with long-term cognitive decline, renal function deterioration, and elevated mortality risk. The recently proposed brain-kidney axis theory suggests that the central nervous system and the kidney communicate bidirectionally through pathways including inflammation, oxidative stress, sympathetic overactivation, and hemodynamic instability, amplifying damage in a cascade manner. This provides an important theoretical framework for understanding the comorbidity mechanism of postoperative delirium and renal injury. Early identification of modifiable preoperative risk factors and blocking abnormal activation of the brain-kidney axis are critical to improving outcomes in cardiac surgery patients.
A growing body of evidence indicates that preoperative sleep disturbance is highly prevalent in surgical patients and represents an independent risk factor for adverse perioperative outcomes. Sleep disruption can disrupt circadian rhythms, exacerbate systemic inflammation, impair neurocognitive function, disturb renal hemodynamic homeostasis, and simultaneously aggravate secondary damage to both the central nervous system and the kidney via the brain-kidney axis, thereby significantly increasing the risk of comorbid postoperative delirium and acute kidney injury. However, most previous studies evaluated sleep using a single total scale score or one-dimensional indicators, which cannot fully capture the complexity and heterogeneity of preoperative sleep architecture.
To date, few studies have explored the associations between preoperative sleep phenotypes and postoperative POD, AKI, or their comorbidity in cardiac surgery based on objective sleep monitoring data and combined with the brain-kidney axis theory. Furthermore, the potential mediating role of postoperative sleep disturbance in these pathways remains unclear.
Therefore, this study aims to identify preoperative sleep phenotypes in cardiac surgery patients using cardiopulmonary coupling-derived objective sleep parameters; to investigate the associations of different sleep phenotypes with postoperative POD, AKI, and their comorbidity; and to further conduct subgroup analyses and mediation analyses to explore effect modifiers and underlying mechanisms, with a particular focus on the pathways through which abnormal sleep affects adverse postoperative outcomes via the brain-kidney axis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative sleep group | – | –The patient underwent cardiopulmonary coupling sleep monitoring one night before operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled for elective cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (1 listed)
- Aged 18 years or above who were scheduled for elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (3 listed)
- Patients undergoing congenital heart disease repair surgery or surgeries necessitating deep hypothermic circulatory arrest were excluded.
- Patients with a history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or neurosurgery were also excluded.
- Patients with a preoperative Mini - Mental State Examination (MMSE) score less than 24 , or those unable to communicate due to coma, severe dementia, or language barriers were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative delirium
Time frame: within 1 week after operation
assessed with 3-minute confusion assessment method (3D-CAM) or confusion assessment method for the ICU (CAM- ICU)
Acute kidney injury
Time frame: within 1 week after operation
assessed with KDIGO criterion
Postoperative delirium combined with acute kidney injury
Time frame: within 1 week after operation
both diagnosed as postoperative delirium and acute kidney injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Hailong Dong study chair
Xijing Hospital
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 Postoperative Delirium and Acute Kidney Injury, run by Xijing Hospital 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 4 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: within 1 week after operation). The study lists 3 primary outcomes in all. 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 4 Aug 2026.