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January 2, 2019 updated by: Jian-jun Yang, Zhongda Hospital

Effects of Frailty on Outcomes After Elective Noncardiac Surgery -a Prospective Cohort Study

Frailty is the clinically recognizable medical condition, also called syndrome or phenotype, that is, the result of processes leading to an increased vulnerability for serious deteriorations in health and the diminished ability to cope with physical stressors. Recently, frailty has emerged as a significant risk factor for adverse postoperative outcomes. It is related to declines in energy, strength, and function as well as to an increased inflammatory state, including elevated levels of interleukin 6 (IL-6), C-reactive protein (CRP), and anelevated white blood cell count . Frailty, as defined Frailty, as defined in the landmark paper by Fried, included at least three of five of the following criteria: unintentional loss of weight, low physical activity, low energy, low grip strength, and a slowed walking speed. Since then, various frailty scoring lists have been designed to optimize the predictive value. One of these is the Edmonton Frail Scale (EFS), an instrument that can be assessed quickly, using only a simple questionnaire which usually does not require more than five minutes to be completed and which covers most domains of functioning, making it easy and fast to get a reliable impression of the degree of frailty.The aim of this study was to determine which factors,with emphasis on frailty, significantly influence postoperative outcome after elective noncardiac surgery as measured by the Comprehensive Complication Index (CCI).

Study Overview

Status

Unknown

Conditions

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 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 to 100 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

≥65 years

Description

Inclusion Criteria:

  • elective noncardiac surgery

Exclusion Criteria:

  • patients who don't cooperate

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
frailty
nonfrailty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
one-year mortality
Time Frame: 2019.02-2020.02
To investigate the one-year mortality of the frailty patients
2019.02-2020.02

Collaborators and Investigators

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

Sponsor

Zhongda Hospital

Investigators

  • Study Chair: Gaojun Teng, PhD, Zhongda Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2018

Primary Completion (Anticipated)

May 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

December 25, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HelP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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