NCT07518992

Brief Summary

To explore the correlation between preoperative sleep parameter clustering and postoperative brain and renal dysfunction.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
549

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

5 days

First QC Date

April 1, 2026

Last Update Submit

April 8, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Postoperative delirium

    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

    assessed with KDIGO criterion

    within 1 week after operation

  • Postoperative delirium combined with acute kidney injury

    both diagnosed as postoperative delirium and acute kidney injury

    within 1 week after operation

Study Arms (1)

Preoperative sleep group

The patient underwent cardiopulmonary coupling sleep monitoring one night before operation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults scheduled for elective cardiac surgery with cardiopulmonary bypass

You may qualify if:

  • Aged 18 years or above who were scheduled for elective cardiac surgery with cardiopulmonary bypass

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence DeliriumAcute Kidney Injury

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Hailong Dong

    Xijing Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Head of Anesthesia Clinical Research Center, Xijing Hospital

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 9, 2026

Study Start

April 10, 2026

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04