Clinical Outcomes in Elderly Patients With Preoperative Cognitive Dysfunction

NCT ID: NCT03143595

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Decline Age Problem Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

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

No interventions assigned to this group

Impaired group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian-jun Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongda Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian-jun Yang, Dr.

Role: CONTACT

13357739238

Mu-huo Ji, Dr

Role: CONTACT

13912975380

Facility Contacts

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Jian-jun Yang, Dr

Role: primary

13357739238

Other Identifiers

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20160530

Identifier Type: -

Identifier Source: org_study_id

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