Frailty Assessment in Cardiac Surgery

NCT04191915 | Completed

• 1 other identifier: HNEAH-KAEK 2019/76
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frailty

Keywords

Aged; Cardiac Surgical Procedures; Coronary Artery Disease; Frail Elderly; Frailty; Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants with Prolonged Length of Stay

  14 days

• Number of Participants with Prolonged Length of Intensive Care Unit Stay

  48 hours

• Number of Participants with Readmission to Intensive Care Unit

  30 days

• Number of Participants with Readmission to hospital

  30 days

Study Arms (3)

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• Age≥65 years
• Planned elective cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: lead
• Turkish Society of Cardiovascular Surgery: collaborator

Study Sites (1)

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

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 30953654 BACKGROUND

• 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.

  PMID: 25332792 BACKGROUND

• 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.

  PMID: 23667068 BACKGROUND

• 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.

  PMID: 24497604 BACKGROUND

• 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.

  PMID: 21378017 BACKGROUND

• 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.

  PMID: 20627611 BACKGROUND

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 24291279 BACKGROUND

• 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.

  PMID: 24864078 BACKGROUND

• 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.

  PMID: 19463525 BACKGROUND

MeSH Terms

Conditions

Frailty; Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ilyas Kayacioglu, M.D.

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: January 15, 2020
• Primary Completion: May 15, 2020
• Study Completion: June 15, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)