- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07518992
Correlation Between Preoperative Sleep and Postoperative Brain and Renal Dysfunction
Correlation Between Preoperative Sleep Parameters Clustering and Postoperative Brain and Renal Dysfunction
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chong Lei
- Phone Number: 18629011362
- Email: crystalleichong@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Aged 18 years or above who were scheduled for elective cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Preoperative sleep group
The patient underwent cardiopulmonary coupling sleep monitoring one night before operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
within 1 week after operation
|
|
Acute kidney injury
Time Frame: within 1 week after operation
|
assessed with KDIGO criterion
|
within 1 week after operation
|
|
Postoperative delirium combined with acute kidney injury
Time Frame: within 1 week after operation
|
both diagnosed as postoperative delirium and acute kidney injury
|
within 1 week after operation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hailong Dong, Xijing Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Renal Insufficiency
- Delirium
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Emergence Delirium
- Acute Kidney Injury
Other Study ID Numbers
- KY20222231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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