Clinical trial NCT02749149: Does Frailty Help Predict Postoperative Outcomes in Cardiac Surgery?
Official title: Assessment of the Frailty Score in Cardiac Surgery and Its Correlation to Cardiac Postoperative Morbidity and Disability - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Heart Valve Diseases
Keywords: Cardiac
Surgery
Frailty
Frail
Patients
Recovery
Morbidity
Outcomes
Mortality
Heart
Perioperative
Disability
WHODAS
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disability-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Mortality
timeFrame: 1 month postoperative
measure: Delirium
timeFrame: 3 days postoperative
measure: In hospital complications
timeFrame: 1 month
measure: Return to theatre
timeFrame: 1 month
measure: Length of hospital stay
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: King's College London
name: Joshua Lucas de Carvalho
role: PRINCIPAL_INVESTIGATOR
References: