Clinical Outcomes in Elderly Patients With Preoperative Cognitive Dysfunction

May 3, 2017 updated by: Jian-jun Yang, Zhongda Hospital

Cognitive Trajectories and Clinical Outcomes in Elderly Patients With Preoperative Cognitive Dysfunction

Preexisting cognitive impairment, such as mild cognitive impairment, is common in many elderly patients who undergoing major surgeries. Accumulating evidence has demonstrated that preexisting cognitive impairment is associated with increased mortality, increased incidence of postoperative complications, decreased quality of life, and worse outcomes. However, few studies have evaluated the relationship between preexisting cognitive impairment and cognitive trajectories and clinical outcomes.

Study Overview

Status

Unknown

Conditions

Detailed Description

Preexisting cognitive impairment is common in many elderly patients who undergoing major surgeries. The number of surgical procedures in the elderly will increase dramatically as a result of the increased elderly population in the future. It has been suggested that preexisting cognitive impairment is associated with increased incidence of postoperative complications, decreased quality of life, and increased mortality. Preoperative risk assessment is becoming increasingly important because preoperative risk stratification allows the clinical team to forecast postoperative outcomes. Currently, the most common strategy to identify high-risk patients before surgery is assessment of single end-organ function. This tactic is most widely recognized by the American Heart Association's guideline for cardiac evaluation, but is also well described for pulmonary, hepatic, and renal organ systems. Little is known about the effects of pre-existing cognitive (or brain) function (perhaps the most vital human organ) on postoperative outcomes. Therefore, the present study evaluated whether patients with pre-operative cognitive impairment would have a more precipitous drop in cognitive function and worse outcome in geriatric surgical patients.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital
        • 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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients were 65 years and older undergoing an elective operation on the general, noncardiac thoracic, urologic, and vascular surgical services.

Description

Inclusion Criteria:

- Inclusion criteria were persons 65 years and older undergoing an elective operation on the general, noncardiac thoracic, urologic, and vascular surgical services.

Exclusion Criteria:

- Patients with vision or hearing impairment who could not visualize pictures or hear instructions associated with the delirium assessments and patients who could not provide informed consent.

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
Control group
Patients in this group have normal cognition as assessed by the validated Mini-Cog test before the elective operation.
Impaired group
Patients in this group have impaired cognition as assessed by the validated Mini-Cog test before the elective operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition changes
Time Frame: 1 year
Cognitive function was assessed at baseline before the elective operation and one year in all subjects using the Mini-Cog test by a member of a trained research team.
1 year

Collaborators and Investigators

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

Sponsor

Zhongda 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)

July 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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