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Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery (FRAIL-HEART)

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ClinicalTrials.gov Identifier: NCT03913299
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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.

Condition or disease
Frail Elderly Syndrome Frailty Surgery

Detailed 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]
  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients older than 18 years of age admitted for cardiac surgery or vascular surgery in Cliniques Universitaires Saint-Luc in Brussels will be included.
Criteria

Inclusion Criteria:

  • Any cardiac surgery under cardiopulmonary bypass
  • Any vascular surgery

Exclusion Criteria:

  • Salvage surgery
  • Cirrhosis CHILD B or C

Information from the National Library of Medicine

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


Contacts
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Contact: Melanie dechamps, MD +3227642782 melanie.dechamps@uclouvain.be

Locations
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Belgium
St Luc University Hospital UCLouvain Recruiting
Brussels, Belgium
Contact: Melanoe Dechamps, MD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Melanie Dechamps, MD St Luc University Hospital UCLouvain

Publications:

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03913299     History of Changes
Other Study ID Numbers: Frail Heart
2019/26FEV/094 ( Other Identifier: CEHF )
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Frailty
Cardiac surgery
Vascular surgery

Additional relevant MeSH terms:
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Frailty
Pathologic Processes