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Quality of LifeAGENCT02535728

Anesthesia Geriatric Evaluation and Quality of Life After Cardiac Surgery

An observational study of Quality of Life, run by St. Antonius Hospital at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 70 years and older
Conditions the study is for
Quality of Life
How many people
577 participants
Where
1 siteNetherlands
Study dates
Jul 2015to 1 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: All patients planned for elective cardiac surgery and aged 70 years or older.

Who may be able to join

  • Aged 70 years or older
  • Mentally competent
  • Planned cardiac surgery (coronary, valvular, rhythm, aortic or combination of those)
  • Signed informed consent

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • St Antonius hospital

    Nieuwegein, Utrecht, 3435 CM

Other trials in Netherlands

About this study

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

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

Read the detailed 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.

Conditions
Quality of Life
Keywords
Frail Elderly, Cardiac Surgical Procedure, Risk Assessment, Quality of Life

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life Assessed by Short Form-36 (SF-36)

    Assessed by Short Form-36 (SF-36)

    Measured: 12 months after surgery

Secondary outcomes (6)

  1. Quality of Life Assessed by Short Form-36 (SF-36)

    Assessed by Short Form-36 (SF-36)

    Measured: 3 months after surgery

  2. 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)

    Measured: 3 and 12 months after surgery

  3. 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).

    Measured: 30 days after surgery

  4. Mortality

    Measured: 30 days and 12 months after surgery

  5. Length of stay in hospital and ICU

    Measured: Post-Surgery. The expected length of stay in the ICU is 1 to 5 days and in hospital 5 to 10 days.

  6. Postoperative delirium

    Delirium according to intensive care delirium screening (ICDSC) or delirium observation screening (DOS)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion1 Dec 2017
  4. Study completion1 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
577 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02535728
Sponsor's protocol ID
NL53243.100.15
Acronym
AGE
Status last verified
Mar 2018
First submitted
24 Aug 2015
Last updated
6 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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. doi: 10.1016/s0003-4975(99)00818-8.

    PubMed 10616989

  • 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.

    PubMed 20172133

  • 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.

    PubMed 21805158

  • 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.

    PubMed 22396586

  • Arends BC, Timmerman L, Vernooij LM, Verwijmeren L, Biesma DH, van Dongen EPA, Noordzij PG, van Oud-Alblas HJB. Preoperative frailty and chronic pain after cardiac surgery: a prospective observational study. BMC Anesthesiol. 2022 Jul 1;22(1):201. doi: 10.1186/s12871-022-01746-x.

    PubMed 35778674

  • Verwijmeren L, Noordzij PG, Daeter EJ, Emmelot-Vonk MH, Vernooij LM, van Klei WA, van Dongen EPA. Preoperative frailty and one-year functional recovery in elderly cardiac surgery patients. J Thorac Cardiovasc Surg. 2023 Sep;166(3):870-878.e6. doi: 10.1016/j.jtcvs.2022.01.032. Epub 2022 Feb 3.

    PubMed 35272845

  • Verwijmeren L, Bosma M, Vernooij LM, Linde EM, Dijkstra IM, Daeter EJ, Van Dongen EPA, Van Klei WA, Noordzij PG. Associations Between Preoperative Biomarkers and Cardiac Surgery-Associated Acute Kidney Injury in Elderly Patients: A Cohort Study. Anesth Analg. 2021 Sep 1;133(3):570-577. doi: 10.1213/ANE.0000000000005650.

    PubMed 34153017

  • Verwijmeren L, Peelen LM, van Klei WA, Daeter EJ, van Dongen EPA, Noordzij PG. Anaesthesia geriatric evaluation to guide patient selection for preoperative multidisciplinary team care in cardiac surgery. Br J Anaesth. 2020 Apr;124(4):377-385. doi: 10.1016/j.bja.2019.12.042. Epub 2020 Feb 14.

    PubMed 32063340

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life, run by St. Antonius Hospital at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life Assessed by Short Form-36 (SF-36) (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02535728, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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