Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery (FRAIL-HEART)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03913299|
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : May 10, 2019
|Condition or disease|
|Frail Elderly Syndrome Frailty Surgery|
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.
The primary objective of this study is to evaluate preoperative frailty in all adult patients undergoing cardiac and vascular surgery.
The secondary objectives are:
- to evaluate the association between frailty and postoperative mortality.
- to evaluate the association between frailty and postoperative functional decline (nursing home admission or care dependency)
- to evaluate impact of each frailty domain on the post-operative outcomes (mortality and functional decline)
- to evaluate how to integrate frailty with the others preoperative clinical parameters to better predict postoperative outcome
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:
- all-cause mortality
- functional decline with admission to a nursing home or care dependency. Care dependency will be defined by a Katz index more than 0 .
Follow-up will be realized by a phone call to the patient, his relatives or his general practitioner.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery "Frail Heart" Study.|
|Actual Study Start Date :||April 23, 2019|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
- Mortality [ Time Frame: 1 year ]
- Functionnal decline [ Time Frame: 1 year ]Admission to a nursing home (yes or no) or care dependency (defined by a Katz index higher than 0/6)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913299
|Contact: Melanie dechamps, MDemail@example.com|
|St Luc University Hospital UCLouvain||Recruiting|
|Contact: Melanoe Dechamps, MD|
|Principal Investigator:||Melanie Dechamps, MD||St Luc University Hospital UCLouvain|