Does Frailty Help Predict Postoperative Outcomes in Cardiac Surgery? (FOCuS)

Assessment of the Frailty Score in Cardiac Surgery and Its Correlation to Cardiac Postoperative Morbidity and Disability - a Prospective Observational Study

This study will assess the benefit in using a frailty score to quantify accurate risk pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity and disability-free survival post-operatively.

Study Overview

• Status: Unknown
• Conditions: Heart Valve Diseases; Coronary Heart Disease

Detailed Description

Increasingly, the group of patients undergoing cardiac surgery are older. Patients that are more elderly and frail are known to have an increase risk of injury to major organs following surgery including the heart, kidneys, and brain, all of which are associated with worse survival or diminished quality of life. It is becoming more important to be able to predict how well patients will fair in cardiac surgery, including predicting risk of complications (such as stroke or heart attacks) as well as long-term survival and quality of life. Currently, scores such as EUROscore can be used with good effect in predicting survival and major complications in cardiac surgery patients. However, frailty - the severity of a patient's weakness or fragility - has emerged as a potential candidate in predicting risk. Recent research has shown frailty score to predict risk of survival and complications following cardiac surgery and suggested to be possibly superior to pre-existing scores. The investigators wish to investigate the possible link between frailty and outcomes following cardiac surgery, in addition to current risk scores. The investigators also wish to determine whether frailty can effectively predict longer-term outcomes such as 'disability-free survival' - a patient-centred score that measures the ability of a patient to lead normal life activities. Patients undergoing major cardiac surgery at King's College Hospital will be recruited, following consent. The study will mainly involve questionnaires at various stages, starting at a pre-operative clinic. After surgery, follow up of patient's progress will be carried out at 3 days in hospital; and at 1 month, 3 months, and 6 months and 1 year via telephone. The investigators expect the results of this observational study to influence further research into the use of frailty risk scoring prior to clinical decisions, and add to the evidence in assessing risk-related outcomes in cardiac surgery.

• Study Type: Observational
• Enrollment (Anticipated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators are planning to recruit 120 adult patients undergoing elective coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery at King's College Hospital, Denmark Hill, London

Description

Inclusion Criteria:

• Aged 18 years or over
• Due to undergo elective cardiac surgery: coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery
• Able to give informed consent
• Fluency in English

Exclusion Criteria:

• Emergency cardiac surgery and non-cardiac surgery
• Inadequate knowledge of English that will prevent patients from completing the consent or undertaking study assessments
• Severe visual, auditory, or motor handicap
• Concurrent diseases of the central nervous system,
• Patients at the extremes of frailty, in whom it would be unethical to perform a full assessment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac Surgery; Patients undergoing cardiac surgery: coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability-free survival	Defined as percentage of participants alive and with a disability score (using World Health Organisation Disability Assessment Schedule 2.0, WHODAS) of less than 25%.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		1 month
Mortality		1 month postoperative
Delirium	Using Confusion Assessment Method (CAM).	3 days postoperative
In hospital complications	Incidence of major adverse cardiac or cerebrovascular events, and/or acute renal injury.	1 month
Return to theatre		1 month

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Joshua Lucas de Carvalho, King's College London

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: April 8, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Recovery; Surgery; Perioperative; Patients; Morbidity; Outcomes; Mortality; Heart; Frailty; Disability; Cardiac; Frail; WHODAS
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Frailty; Heart Valve Diseases
• Other Study ID Numbers: KCH16-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Contact research lead.