1. To determine the influence of frailty on predicting an increase in HRQL in elderly cardiac surgery patients .2. To develop an AGE score for predicting an increase in HRQL after cardiac surgery based on surgical risk factors, comorbidities and…
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpunt is an increase >4 points of the physical or mental component
score of the SF-36 health status 12 months after cardiac surgery.
Secondary outcome
Secundary endpoints are incidence of postoperative complications, length of ICU
and hospital stay, HRQL at 3 months, mortality at 30 days and 12 months.
Background summary
Cardiac surgery in elderly patients is associated with risk of postoperative
morbidity, mortality, loss of self-reliance and decreased health related
quality of life (HRQL). Such risk is further increased in frail patients.
Frailty results in loss of functional capacity and is characterised by weight
loss, sarcopenia and decreases physical activity. The influence of frailty on
postoperative outcome after cardiac surgery is not implemented in current
international risk prediction models.
Study objective
1. To determine the influence of frailty on predicting an increase in HRQL in
elderly cardiac surgery patients .
2. To develop an AGE score for predicting an increase in HRQL after cardiac
surgery based on surgical risk factors, comorbidities and frailty.
3. To determine the additional predictive effect of pre-operative non-invasive
measurement of AGEs (Advanced Glycation Endproducts) using skinautoflurenscence
in predicting an increase in HRQL.
Study design
Prospective, observational, cohort study. Patients are followed up for 1 year.
Primary endpoint is an increase in HRQL.
Study burden and risks
This is an observational study, there is no associated risk for the patient. It
takes 30 minutes to perform the additional questionnaire, 3 physical tests and
1 AGE reader test. It takes 9 minutes to complete the SF-36 health status
questionnaire at 3 and 12 months each.
Preoperative screening at the anesthesiology outpatient clinic
Study patients undergo regular anesthesia screening prior to surgery at the
outpatient anesthesia clinic, similar to patients not included in the study.
The results of the additional questionnaire and tests hold no consequences for
whether or not the patient proceeds to surgery. After visiting the outpatient
clinic a study patient receives regular preoperative cardiac care, similar to
patients not included in the study.
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
Inclusion criteria
age ><=70
elective cardiac surgery
Exclusion criteria
age <70
urgent cardiac surgery
noncardiac surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53243.100.15 |