Anesthesia Geriatric Evaluation and Quality of Life After Cardiac Surgery

Quality of Life Clinical Trial

— AGE  

Official title:

Anesthesia Geriatric Evaluation and the Prediction of Quality of Life in Elderly Cardiac Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535728
• Other study ID #: NL53243.100.15
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: March 4, 2018
• Start date: July 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2018
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in cardiac surgery patients.

Description:

Introduction:

The current population is ageing in a rapid pace. Currently elderly represent 17.8% of the Dutch population. Most recent estimates show this will increase to 25.6% 20 years' time. This rise in elderly will also reflect on the population of patients being referred for cardiac surgery. Especially elderly patients are at risk for postoperative complications, mortality or functional decline. In frail elderly this effect might be more pronounced. Frailty is an umbrella term that encompasses patient related factors such as weight loss, muscle wasting, inactivity, comorbidities and polypharmacy. Current scoring systems that are used to predict postoperative mortality and complications following cardiac surgery perform poorly in the elderly population and do not take into account frailty. Moreover they are designed to predict mortality and complications and are not validated to predict patient reported outcome measures such as quality of life or functional status. The aim of the AGE study is assess the value of frailty factors in predicting an improvement in quality of life one year after cardiac surgery.

Methods:

The AGE study is a prospective observational cohort study. All patients aged 70 years or older, scheduled for cardiac surgery, mentally competent and have signed informed consent are eligible for the study. During routine preoperative screening patients will be screened for frailty using different questionnaires and physical tests. The battery of tests exist of Short Form 36 (SF36), Multi Nutritional Assessment (MNA), Mini Mental State Examination (MMSE) and Nagi's scale for disability, Three physical tests: five meter walking speed, timed get up and go test and hand grip strength. A non-invasive measurement of Advanced Glycation Endproducts (AGEs) and a medication review. A blood sample will be taken to determine vitamin status, iron deficiency, pre-operative inflammatory parameters, CMV status, pneumococcal carriage and cardiac biomarkers. After surgery electronic patients charts will be studied to score postoperative complications or mortality. Three months and one year after cardiac surgery patients will receive SF-36 and World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaires to determine quality of life and functional status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Aged 70 years or older

• Mentally competent

• Planned cardiac surgery (coronary, valvular, rhythm, aortic or combination of those)

• Signed informed consent

Related Conditions & MeSH terms

• Quality of Life

Locations

Country	Name	City	State
Netherlands	St Antonius hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Afilalo J, Mottillo S, Eisenberg MJ, Alexander KP, Noiseux N, Perrault LP, Morin JF, Langlois Y, Ohayon SM, Monette J, Boivin JF, Shahian DM, Bergman H. Addition of frailty and disability to cardiac surgery risk scores identifies elderly patients at high risk of mortality or major morbidity. Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):222-8. doi: 10.1161/CIRCOUTCOMES.111.963157. Epub 2012 Mar 6. — View Citation

Chaturvedi RK, Blaise M, Verdon J, Iqbal S, Ergina P, Cecere R, deVarennes B, Lachapelle K. Cardiac surgery in octogenarians: long-term survival, functional status, living arrangements, and leisure activities. Ann Thorac Surg. 2010 Mar;89(3):805-10. doi: 10.1016/j.athoracsur.2009.12.002. — View Citation

Ettema RG, Peelen LM, Kalkman CJ, Nierich AP, Moons KG, Schuurmans MJ. Predicting prolonged intensive care unit stays in older cardiac surgery patients: a validation study. Intensive Care Med. 2011 Sep;37(9):1480-7. doi: 10.1007/s00134-011-2314-1. Epub 2011 Jul 30. — View Citation

Fruitman DS, MacDougall CE, Ross DB. Cardiac surgery in octogenarians: can elderly patients benefit? Quality of life after cardiac surgery. Ann Thorac Surg. 1999 Dec;68(6):2129-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Assessed by Short Form-36 (SF-36)	Assessed by Short Form-36 (SF-36)	12 months after surgery
Secondary	Quality of Life Assessed by Short Form-36 (SF-36)	Assessed by Short Form-36 (SF-36)	3 months after surgery
Secondary	Psychosocial or physical functioning Assessed by World Health Organisation Disability Assessment Schedule 2.0	Assessed by World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)	3 and 12 months after surgery
Secondary	Incidence of postoperative complications	Postoperative complications are scored according to Dutch national guidelines on reporting complications in cardiac surgery and include rethoracotomy, reoperation, bleeding, arrythmia, stroke, myocardial infarction, deep sternal wound infection, pneumonia, urinary tract infection, sepsis, respiratory insufficiency, prolonged respiratory support and renal failure (AKI).	30 days after surgery
Secondary	Mortality		30 days and 12 months after surgery
Secondary	Length of stay in hospital and ICU		Post-Surgery. The expected length of stay in the ICU is 1 to 5 days and in hospital 5 to 10 days.
Secondary	Postoperative delirium	Delirium according to intensive care delirium screening (ICDSC) or delirium observation screening (DOS)	30 days