NCT03143595

Brief Summary

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.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

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

July 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

April 26, 2017

Last Update Submit

May 3, 2017

Conditions

Keywords

Preexisting cognitive impairmentElderlyOutcomes

Outcome Measures

Primary Outcomes (1)

  • Cognition changes

    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

Study Arms (2)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Jian-jun Yang, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 8, 2017

Study Start

July 1, 2016

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

May 8, 2017

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations