NCT05772026

Brief Summary

Patients undergoing cardiac surgery were recruited. Baseline characteristics of all subjects were collected. The 3-minute Delirium diagnostic Scale (3D-CAM) was used to screen the POD group and non-POD group from the recruited subjects during the first 7 days after surgery. Peripheral blood samples were collected 1 day before surgery and 2 day after surgery. . Plasma was isolated from peripheral blood for subsequent proteomic analysis.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 16, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

February 18, 2023

Last Update Submit

March 5, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Differences of Quantitative Proteomics between POD and non-POD

    Plasma was isolated from peripheral blood for subsequent proteomic analysis. Investigators study the characteristics of proteins at a large-scale level.

    1 day before surgery

  • Differences of Quantitative Proteomics between POD and non-POD after surgery

    Plasma was isolated from peripheral blood for subsequent proteomic analysis. Investigators study the characteristics of proteins at a large-scale level.

    2 day after surgery

Study Arms (2)

POD group

According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group

non-POD group

According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cardiac Surgery.

You may qualify if:

  • Age ≥65 years old, regardless of gender.
  • The patient had clear consciousness and no cognitive impairment, and could cooperate with the investigation and follow-up.
  • The ASA classification is I-Ⅲ.

You may not qualify if:

  • severe neurological or psychiatric disorders.
  • drug and alcohol abuse.
  • Patients with cognitive impairment caused by various reasons such as neuropsychiatric symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Yangzi Zhu, Doctor

    Xuzhou Central Hospital

    STUDY DIRECTOR
  • Liwei Wang, Doctor

    Xuzhou Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yangzi Zhu, Doctor

CONTACT

Liwei Wang, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 16, 2023

Study Start

March 20, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

March 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share