Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery

January 14, 2022 updated by: Jun Ma, Beijing Anzhen Hospital

Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery：A Prospective Observational Cohort Study

Delirium is an acute brain lesion characterized by abnormalities of consciousness, attention, cognition and sensation. Many brain diseases such as stroke, traumatic brain injury and intracranial hypertension can lead to cardiac insufficiency, arrhythmia and heart failure. The incidence of postoperative delirium in patients undergoing cardiac surgery is high. Postoperative delirium is a manifestation of brain function injury. The effect of postoperative delirium on postoperative cardiac function in patients undergoing cardiac surgery is worthy of further discussion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

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
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Anzhen hospital, Beijing
        • Contact:

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

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing valvular surgery in our hospital were selected. The age was 60 years ≤ age ≤75 years, and gender was not limited. According to the occurrence of postoperative delirium, the patients were divided into postoperative delirium group and Non-postoperative delirium group.

Description

Inclusion Criteria:

  • Patients undergoing valvular surgery
  • Age between 60 to 75

Exclusion Criteria:

  • Have a history of cerebral infarction before operation
  • Cardiac function was seriously impaired before surgery
  • Neuropsychiatric disorders were present before surgery

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The group with delirium
Other: No intervention
No intervention
The group without delirium
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart function
Time Frame: up to 60 days
Doses of norepinephrine, epinephrine, dopamine, dobutamine and vasopressin
up to 60 days

Collaborators and Investigators

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

Sponsor

Beijing Anzhen 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)

January 1, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220101

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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