Frailty Assessment in Cardiac Surgery

November 3, 2020 updated by: Kamile Ozeren Topcu, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Assessment of Frailty in Elderly Patients Undergoing Elective Cardiac Surgery

With increasing life expectancy, cardiac surgical procedures are increasingly being performed in older adults. The biological syndrome of frailty is an aging-associated state with diminished physiological reserve and resistance to stressors, such as major surgery. In the European System for Cardiac Operative risk Evaluation (EuroSCORE II) and the Society of Thoracic Surgeons (STS) risk scoring systems, patient comorbidities including advanced age and poor mobility are considered as risk factors for operative mortality. However, an objective assessment of frailty is not included. Traditionally, frailty assessment before cardiac surgery is primarily performed based on surgeon's subjective perception of patient's general appearance. Objective measurement of frailty is increasingly being applied as a routine part of preoperative evaluation of elderly patients undergoing cardiac surgery. The most widely used frailty assessment tool is the Fried scale. The investigators aim to investigate whether Fried scale would predict operative mortality and morbidity in elderly patients undergoing elective cardiac surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

Consecutive patients who are scheduled to undergo elective cardiac surgery in Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital will be evaluated for enrollment. Those who meet inclusion and exclusion criteria will be invited to be study participants. Volunteers will constitute the study population. All participants will undergo routine preoperative risk assessment procedures of our institution, which include history, physical examination, blood chemistry, chest X-ray, echocardiogram, and spirometry. As part of this routine assessment, Fried scale (5-meter walk test, hand-grip strength, questioning of weight loss, short version of the Center for Epidemiological Studies-Depression scale, and short version of the Minnesota Leisure Time Physical Activity questionnaire) will be applied to all participants. Demographics characteristics and clinical data will be observed and recorded. Participants will be divided into 3 groups according to Fried scale; frail, moderately frail, and not frail.

In order to investigate the ability of Fried scale to predict cardiac operative mortality and morbidity, groups will be compared in terms of surgical mortality, renal failure, stroke, prolonged mechanical ventilation, deep sternal wound infections, re-operation, prolonged length of stay, and readmission rates.

Power analysis was performed to estimate sample size using G*Power (v3.1.7) software. A total 150 participants are needed in order to achieve an 80% (Beta=0.2) power at the 5% (Alpha=0.05) level of significance.

Categorical data will be presented as frequency and percentage. Continuous variables will be presented as mean [±standard deviation] and median [interquartile range]. Categorical variables will be compared using chi-square and Fisher's exact tests. Kolmogorov-Smirnov test will be used to assess distribution of continuous variables. Continuous variables with a normal distribution will be compared using Student's t-test, and those with a non-normal distribution will be compared using Mann-Whitney U test.

SPSS for Windows v.17.0 (SPSS Statistics Inc., Chicago, Ill., USA) will be used for all statistical analyses. A two-sided p value of <0.05 will be considered to be statistically significant.

Study Type

Observational

Enrollment (Actual)

164

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

  • Turkey
      • Istanbul, Turkey, 34668
        • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

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 scheduled to undergo elective cardiac surgery in Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Description

Inclusion Criteria:

  • Age≥65 years
  • Planned elective cardiac surgery

Exclusion Criteria:

  • Age<65 years
  • Emergent procedure
  • Refusal to participate
  • Clinical instability (recent myocardial infarction, decompensated cardiac failure, acutely symptomatic participants, abnormal vital signs)
  • Canadian Cardiovascular Society grade IV angina pectoris
  • New York Heart Association class IV heart failure
  • Failure to cooperate due to neuropsychiatric disorders

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
Frail
Participants with 3 or more components of Fried frailty scale
Moderately Frail
Participants with 1-2 components of Fried frailty scale
Not Frail
Participants without any components of Fried frailty scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Operative Mortality or Major Morbidity
Time Frame: 30 days

Composite endpoint defined by The Society of Thoracic Surgeons. Operative mortality is defined as death occurring within 30 days after surgery, or during the same hospitalization following surgery.

Major morbidity includes permanent stroke, renal failure, prolonged ventilation, deep sternal wound infection, re-operation for any reason.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Prolonged Length of Stay
Time Frame: 14 days
Failure to be discharged within 14 days of surgery
14 days
Number of Participants with Prolonged Length of Intensive Care Unit Stay
Time Frame: 48 hours
Length of intensive care unit stay ≥ 48 hours
48 hours
Number of Participants with Readmission to Intensive Care Unit
Time Frame: 30 days
Unplanned readmission to intensive care unit during index hospitalization
30 days
Number of Participants with Readmission to hospital
Time Frame: 30 days
Rehospitalization for any reason within 30 days of discharge
30 days

Collaborators and Investigators

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

Sponsor

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Collaborators

Turkish Society of Cardiovascular Surgery

Investigators

  • Study Director: Ilyas Kayacioglu, M.D., Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research 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)

January 15, 2020

Primary Completion (ACTUAL)

May 15, 2020

Study Completion (ACTUAL)

June 15, 2020

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 7, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNEAH-KAEK 2019/76

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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