Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery

Surgery Clinical Trial

— FRAIL-HEART  

Official title:

Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery "Frail Heart" Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03913299
• Other study ID #: Frail Heart
• Secondary ID: 2019/26FEV/094
• Status: Recruiting
• Start date: April 23, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Melanie dechamps, MD
• Phone: +3227642782
• Email: melanie.dechamps[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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:

• 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

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:

• 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 [19].

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2080
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any cardiac surgery under cardiopulmonary bypass

• Any vascular surgery

Exclusion Criteria:

• Salvage surgery

• Cirrhosis CHILD B or C

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty
• Surgery

Locations

Country	Name	City	State
Belgium	St Luc University Hospital UCLouvain	Brussels
Belgium	Grand Hopital Charleroi	Charleroi
Belgium	Centre Hospitalier Universitaire de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		1 year
Primary	Functionnal decline	Admission to a nursing home (yes or no) or care dependency (defined by a Katz index higher than 0/6)	1 year