NCT06194474

Brief Summary

To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 5, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

December 16, 2023

Last Update Submit

January 4, 2024

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • Proteomics

    Proteomic data will be obtained by LC-MS/MS Analysis-DIA(Data Independent Acquisition) platform

    1 month

Study Arms (2)

Delirium Group

No Delirium Group

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.

You may qualify if:

  • patients between 55 and 80 years old,
  • American Society of Anesthesiologists (ASA) physical status of II-III and New York Heart Association grade of II-III.
  • The planned cardiac surgery.
  • Hospitalization duration not less than 5 days.
  • The anesthesia time will be no less than 2 hours.All patients had a normal ability to hear, read and cooperate with neuropsychological tests.

You may not qualify if:

  • The pre-operative Montreal Cognitive Assessment (MoCA) score was less than 25,
  • Patients with dementia, history of neurological or psychiatric disease, hospital with anxiety depression scale (HADS) over eight points,
  • Currently use sedatives or antidepressants, Patients with substance dependence on drugs or alcohol.
  • Patients with liver and kidney dysfunction, patients with a history of cardiac surgery.
  • Admitted to the ICU for more than two days within the month preceding the current surgery,
  • Unable to cooperate with researcher's investigations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuhui Yan

Jining, Shandong, 272000, China

RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Fuhui Yan

CONTACT

155 8733 5175richardcarryon@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

December 16, 2023

First Posted

January 8, 2024

Study Start

September 5, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

CN(1)