Frailty Assessment in Cardiac Surgery

Frailty Clinical Trial

Official title:

Assessment of Frailty in Elderly Patients Undergoing Elective Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04191915
• Other study ID #: HNEAH-KAEK 2019/76
• Status: Completed
• Start date: January 15, 2020
• Est. completion date: June 15, 2020

Study information

• Verified date: November 2020
• Source: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: June 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Locations

Country	Name	City	State
Turkey	Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital	Turkish Society of Cardiovascular Surgery

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Sündermann 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. — View Citation

Sündermann 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. — View Citation

Sündermann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Operative Mortality or Major Morbidity	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	Number of Participants with Prolonged Length of Stay	Failure to be discharged within 14 days of surgery	14 days
Secondary	Number of Participants with Prolonged Length of Intensive Care Unit Stay	Length of intensive care unit stay = 48 hours	48 hours
Secondary	Number of Participants with Readmission to Intensive Care Unit	Unplanned readmission to intensive care unit during index hospitalization	30 days
Secondary	Number of Participants with Readmission to hospital	Rehospitalization for any reason within 30 days of discharge	30 days