The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
NCT06469437
Diabetes Mellitus, Diabetes Mellitus, Type 2
Porto Alegre, Rio Grande do Sul, Brazil
View Trial DetailsNCT Number: NCT03913299
The aim of the study is to assess frailty of patients admited for cardio-vascular surgery in Cliniques Universitaires Saint Luc in Brussels. And analyse the correlation between frailty, functionnal decline and postoperative mortality.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
St Luc University Hospital UCLouvain, Brussels, Belgium
Frailty is a state of loss of functional reserve resulting in an increased vulnerability to a stressor event. From a pathophysiological point of view, it is an accelerated decrease in physiological reserve related to ageing.
Currently, evaluation of the outcome after cardiac surgery is commonly based on scores not taking into account the concept of frailty (Society of Thoracic Surgeons (STS) and Eurosore II) Recent studies have shown an independent association between post cardiac surgery mortality and pre-operative frailty. Beyond cardiac surgery, frailty has been shown to be associated with higher mortality and morbidity among intensive care unit (ICU) patients. Frailty is commonly assessed for patients older than 75 years of age but the prevalence in younger patients admitted to the hospital is significant. There is therefore need to evaluate all patients for frailty in the preoperative period.
Since the Edmonton Frail Scale (EFS) allows easy screening of all frailty domains, we hypothesized that it could be a reliable and feasible score to assess preoperative frailty and to predict postoperative morbidity and mortality.
Objectives:
The primary objective of this study is to evaluate preoperative frailty in all adult patients undergoing cardiac and vascular surgery.
The secondary objectives are:
Measurement:
Assessment of frailty will be performed using EFS. Other clinical conditions related to frailty will be collected: Body Mass Idex (BMI), tobacco use, alcohol consumption, preoperative albumin and pre-albumin level. STS and Eurosore II will be systematically calculated.
A one-year follow-up will assess the following parameters:
Follow-up will be realized by a phone call to the patient, his relatives or his general practitioner.
Based on a prevalence of frailty of 11%, we have determined that the enrollment of a minimum of 2080 patients would provide a power of 80% at a significance level of 5% to detect a difference of 5% mortality at one year between frail and non-frail patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
Time frame: 1 year
Admission to a nursing home (yes or no) or care dependency (defined by a Katz index higher than 0/6)
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Other
Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery "Frail Heart" Study.
Acronym: FRAIL-HEART
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