Frailty In Cardiac Surgery Copenhagen Study

Summary

Background:

Over the past decades there have been seen an increase in life expectancy in Denmark. One of the consequences is that the patients who need heart surgery have a higher average age and some of these patients have a fragile physique that increases the risks of major surgery.

In cardiac surgery, there are different types of scoring system for assessing the preoperative risk of death associated with surgery. Among them are EuroSCORE and STS systems the most used.

This study evaluate the preoperative risk using the frailty score system, CAF (comprehensive assessment of frailty), based on an assessment of the patient's physical condition. If the patient has a lower than expected physical condition, the patient is frail. The assessment of the physical condition generated from questions about the patient's medical history and physical activity as well as performing less physical tests, consisting of strength, balance and walking speed.

Purpose:

A prospective observational study, who investigates how many of the patients who must undergo heart surgery, that is frail. Then compare the patients who are frail with non-frail patients in terms of complications, mortality and quality of life after the procedure. By use of CAF score the patients are scored frail or non-frail. There is planned a further study which compare degree of kidney injury in frail with non-frail patients. Our assumption is that patients which are frail, have an increased risk of complications and longer hospital stay, higher consumption of intensive days and more readmissions. Using frailty score in combination with the existing score systems EuroSCORE and STS score, are believed to be a better predictor of complications following heart surgery.

Method:

FICS study is a prospective observational study of patients undergoing cardiac surgery in the cardiothoracic department of Rigshospitalet. Planned to enroll 600 patients over a two year period. The study consists of various smaller physical test and questions. Which is used to assess whether the patient is frail and not frail.

Postoperatively follow-up after 30 days with a phone call and after 12 months through danish data register. At the both follow-up times, data are collected on the somatic readmissions / diagnoses and vital status through the national register and review of relevant journal notes. Afterwards comparing complications and mortality.

Who can enter:

One patients can be included if the following criteria are met: Age\> 65 years, Elective or subacute surgery, CABG (coronary artery bypass grafting),valve substitution or combination of these

If one or more of the following criteria are met, the patient is not included in the study:

Acute surgery, Clinical unstable, Severe neuropsychiatric impairment, Uncooperative (psychiatric diagnosis) and Re-operations.

Side effects, risks and disadvantages:

Today preoperative risk assessment are assessed by EuroSCORE. Introduction of CAF, frailty score will not expose patients to the risk or side effect, since the course or treatment does not change.

Economy:

There are considered that the study are economically justified, since hypothetically this would lead to fewer readmissions, fewer days in intensive care and shorter hospital.

Acquisition:

The patients will in this trial be over 65 years old and must have completed elective or subacute cardiac surgery. They will receive participant information and thus the opportunity to read about the study before the first appearance.

At first appearance they meet our project assistant and get here verbal information about the study, where also questions can be answered. Subsequently, the patients will be asked to sign a consent form.

Publication of test results / research ethics statement:

The knowledge and results obtained through the survey will provide essential scientific information of significance for the future course and treatment of patients undergoing cardiac surgery with regard to the number of hospital days, intensive days and readmissions. Thus, the investigator believes that the study is appropriate and ethically

Conditions

• Comprehensive Assessment of Frailty

Interventions

OTHER

CAF, Comprehensive assessment of frailty

CAF, Comprehensive assessment of frailty. A scoring system of the patients physical status. By smaller physical test of balance, strength and walking speed.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2018-07-31

Completion

2020-12-31