Correlation Between Preoperative Sleep and Postoperative Brain and Renal Dysfunction

April 8, 2026 updated by: Chong Lei, MD & phD, Xijing Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
549

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults scheduled for elective cardiac surgery with cardiopulmonary bypass

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Preoperative sleep group
The patient underwent cardiopulmonary coupling sleep monitoring one night before operation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hailong Dong, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20222231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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