Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients

January 4, 2024 updated by: Fuhui Yan, Jining First People's Hospital
To evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

24

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 Locations

  • China
    • Shandong
      • Jining, Shandong, China, 272000

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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
Delirium Group
No Delirium Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteomics
Time Frame: 1 month
Proteomic data will be obtained by LC-MS/MS Analysis-DIA(Data Independent Acquisition) platform
1 month

Collaborators and Investigators

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

Sponsor

Jining First People's 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 (Actual)

September 5, 2022

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

December 16, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Estimated)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JNFPH-2023-01

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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