Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000380392
Ethics application status
Approved
Date submitted
2/03/2017
Date registered
14/03/2017
Date last updated
22/10/2021
Date data sharing statement initially provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of frailty and obesity on the complication rates following cardiac surgery
Scientific title
Frailty, obesity and adverse outcomes in cardiac surgical patients (FOCuS): a prospective study
Secondary ID [1] 291333 0
Nil Known
Universal Trial Number (UTN)
U1111-1193-6823
Trial acronym
FOCuS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 302324 0
Obesity 302376 0
Cardiac surgery 302377 0
Condition category
Condition code
Diet and Nutrition 301908 301908 0 0
Obesity
Cardiovascular 301957 301957 0 0
Other cardiovascular diseases
Surgery 301958 301958 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Measurement of obesity measures such as BMI, neck circumference, waist circumference and waist to hip ratio: brief preoperative assessment the day before surgery.

2. Measurement of frailty by gait speed during a brief preoperative assessment the day before surgery.
The followup for these participants for adverse outcomes will continue until 2 years post surgery
Intervention code [1] 297368 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301338 0
Any one of the following major adverse events (AE) prior to hospital discharge following index procedure by review of cardiothoracic surgery database whereby the details are collected by daily patient followup until discharge.
1. Prolonged ventilation (>24 hours)
2. Prolonged ICU stay (>72 hours)
3. Return to operating theatre: any cause
4. Reoperation for bleeding
5. Perioperative MI
6. New atrial arrhythmia
7. New brady arrhythmia or heart block requiring permanent pacemaker
8. Cardiac arrest
9. Low cardiac output
10. New renal failure
11. New cerebrovascular event
12. Deep sternal wound infection
13. New vascular complication
14. Pneumonia
15. Pulmonary embolism
16. Readmission to ICU
17. Multi-organ failure
18. All cause mortality
Timepoint [1] 301338 0
prior to hospital discharge
Secondary outcome [1] 332331 0
Length of stay in hospital following index admission (from admission till day of discharge or death)
Timepoint [1] 332331 0
prior to hospital discharge
Secondary outcome [2] 332332 0
Days alive and out of hospital (DAOH) from surgery to 30 days following operation. This information collected by phone calls, email survey, followup during outpatient visit, GP contact.
Timepoint [2] 332332 0
30 days post surgery
Secondary outcome [3] 332333 0
Survival rates
Timepoint [3] 332333 0
2 years
Secondary outcome [4] 332479 0
Costs of admission for the index operation
Timepoint [4] 332479 0
by data linkage to the medicare cost records

Eligibility
Key inclusion criteria
All elective and urgent cardiac procedures including CABG or valvular surgery or both along with any other concomitant procedure at The Prince Charles Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients <18 years old
Pregnant women
Emergency cardiac procedures
Repair of congenital heart pathologies, transplants, isolated aortic wall, thoracic or other vascular procedures.
Refusal of consent
Secondary procedures during the same admission

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
2/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1700
Accrual to date
394
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7596 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 15495 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 295811 0
Hospital
Name [1] 295811 0
The Prince Charles Hospital
Country [1] 295811 0
Australia
Primary sponsor type
Individual
Name
Usha Gurunathan
Address
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside,Brisbane, Queensland, Australia- 4032
Country
Australia
Secondary sponsor category [1] 294660 0
None
Name [1] 294660 0
Address [1] 294660 0
Country [1] 294660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297098 0
Metro North Human Research Ethics Committe, The Prince Charles Hospital, Brisbane, Australia
Ethics committee address [1] 297098 0
Ethics committee country [1] 297098 0
Australia
Date submitted for ethics approval [1] 297098 0
01/03/2017
Approval date [1] 297098 0
06/03/2017
Ethics approval number [1] 297098 0
HREC/17/QPCH/59

Summary
Brief summary
Prevalence of obesity is increasing. Contrary to popular belief, literature has shown that overweight and mildly obese have infact been shown to have increased survival benefit compared to normal weight in non-cardiac and cardiac conditions. All the studies that have reported this paradoxical relationship were based on BMI; BMI is not a measure of body fat. This study is to investigate the association between obesity and postoperative in-hospital adverse outcomes following elective cardiac surgery. Several measures of obesity will be compared including BMI, WC, HC, NC and WHR . We will also be measuring body frailty and its association with adverse outcomes. The patients will be followed up until 2 years through phone contact and registries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47930 0
Dr Usha Gurunathan
Address 47930 0
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside,Brisbane, Queensland, Australia- 4032
Country 47930 0
Australia
Phone 47930 0
+61 7 3139 4000
Fax 47930 0
Email 47930 0
usha.nathan@health.qld.gov.au
Contact person for public queries
Name 47931 0
Usha Gurunathan
Address 47931 0
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside,Brisbane, Queensland, Australia- 4032
Country 47931 0
Australia
Phone 47931 0
+61 7 3139 4000
Fax 47931 0
Email 47931 0
usha.gurunathan@health.qld.gov.au
Contact person for scientific queries
Name 47932 0
Usha Gurunathan
Address 47932 0
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside,Brisbane, Queensland, Australia- 4032
Country 47932 0
Australia
Phone 47932 0
+61 7 3139 4000
Fax 47932 0
Email 47932 0
usha.gurunathan@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Additional individual data just involves some measurements and frailty assessments. This knowledge would not be beneficial to an individual patient. The rest of the data would be extracted from cardiothoracic database.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.