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Frailty Assessment in Cardiac Surgery

NCT ID: NCT04191915

Last Updated: 2020-11-04

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

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-15

Study Completion Date

2020-06-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Frailty

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Frail

Participants with 3 or more components of Fried frailty scale

No interventions assigned to this group

Moderately Frail

Participants with 1-2 components of Fried frailty scale

No interventions assigned to this group

Not Frail

Participants without any components of Fried frailty scale

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkish Society of Cardiovascular Surgery

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Kamile Ozeren Topcu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilyas Kayacioglu, M.D.

Role: STUDY_DIRECTOR

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

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Henry L, Halpin L, Barnett SD, Pritchard G, Sarin E, Speir AM. Frailty in the Cardiac Surgical Patient: Comparison of Frailty Tools and Associated Outcomes. Ann Thorac Surg. 2019 Jul;108(1):16-22. doi: 10.1016/j.athoracsur.2019.03.009. Epub 2019 Apr 3.

Reference Type BACKGROUND
PMID: 30953654 (View on PubMed)

Rowe R, Iqbal J, Murali-Krishnan R, Sultan A, Orme R, Briffa N, Denvir M, Gunn J. Role of frailty assessment in patients undergoing cardiac interventions. Open Heart. 2014 Feb 1;1(1):e000033. doi: 10.1136/openhrt-2013-000033. eCollection 2014.

Reference Type BACKGROUND
PMID: 25332792 (View on PubMed)

Bagnall NM, Faiz O, Darzi A, Athanasiou T. What is the utility of preoperative frailty assessment for risk stratification in cardiac surgery? Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):398-402. doi: 10.1093/icvts/ivt197. Epub 2013 May 10.

Reference Type BACKGROUND
PMID: 23667068 (View on PubMed)

Sundermann SH, Dademasch A, Seifert B, Rodriguez Cetina Biefer H, Emmert MY, Walther T, Jacobs S, Mohr FW, Falk V, Starck CT. Frailty is a predictor of short- and mid-term mortality after elective cardiac surgery independently of age. Interact Cardiovasc Thorac Surg. 2014 May;18(5):580-5. doi: 10.1093/icvts/ivu006. Epub 2014 Feb 3.

Reference Type BACKGROUND
PMID: 24497604 (View on PubMed)

Sundermann S, Dademasch A, Rastan A, Praetorius J, Rodriguez H, Walther T, Mohr FW, Falk V. One-year follow-up of patients undergoing elective cardiac surgery assessed with the Comprehensive Assessment of Frailty test and its simplified form. Interact Cardiovasc Thorac Surg. 2011 Aug;13(2):119-23; discussion 123. doi: 10.1510/icvts.2010.251884. Epub 2011 Mar 4.

Reference Type BACKGROUND
PMID: 21378017 (View on PubMed)

Sundermann S, Dademasch A, Praetorius J, Kempfert J, Dewey T, Falk V, Mohr FW, Walther T. Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery. Eur J Cardiothorac Surg. 2011 Jan;39(1):33-7. doi: 10.1016/j.ejcts.2010.04.013.

Reference Type BACKGROUND
PMID: 20627611 (View on PubMed)

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

Reference Type BACKGROUND
PMID: 11253156 (View on PubMed)

Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27.

Reference Type BACKGROUND
PMID: 24291279 (View on PubMed)

Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26.

Reference Type BACKGROUND
PMID: 24864078 (View on PubMed)

Afilalo J, Karunananthan S, Eisenberg MJ, Alexander KP, Bergman H. Role of frailty in patients with cardiovascular disease. Am J Cardiol. 2009 Jun 1;103(11):1616-21. doi: 10.1016/j.amjcard.2009.01.375. Epub 2009 Apr 8.

Reference Type BACKGROUND
PMID: 19463525 (View on PubMed)

Other Identifiers

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HNEAH-KAEK 2019/76

Identifier Type: -

Identifier Source: org_study_id