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

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. Read our disclaimer for details. Identifier: NCT02749149
Recruitment Status : Unknown
Verified April 2016 by King's College Hospital NHS Trust.
Recruitment status was:  Enrolling by invitation
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Information provided by (Responsible Party):
King's College Hospital NHS Trust

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.

Condition or disease
Coronary Heart Disease Heart Valve Diseases

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Frailty Score in Cardiac Surgery and Its Correlation to Cardiac Postoperative Morbidity and Disability - a Prospective Observational Study
Study Start Date : January 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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

Primary Outcome Measures :
  1. Disability-free survival [ Time Frame: 1 year ]
    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%.

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1 month postoperative ]
  2. Delirium [ Time Frame: 3 days postoperative ]
    Using Confusion Assessment Method (CAM).

  3. In hospital complications [ Time Frame: 1 month ]
    Incidence of major adverse cardiac or cerebrovascular events, and/or acute renal injury.

  4. Return to theatre [ Time Frame: 1 month ]
  5. Length of hospital stay [ Time Frame: 1 month ]

Information from the National Library of Medicine

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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
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

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.

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 identifier (NCT number): NCT02749149

Sponsors and Collaborators
King's College Hospital NHS Trust
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Principal Investigator: Joshua Lucas de Carvalho King's College London

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Responsible Party: King's College Hospital NHS Trust Identifier: NCT02749149     History of Changes
Other Study ID Numbers: KCH16-012
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Contact research lead.

Keywords provided by King's College Hospital NHS Trust:

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Valve Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Pathologic Processes