Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001455752
Ethics application status
Approved
Date submitted
29/10/2022
Date registered
14/11/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
14/11/2022
Date results information initially provided
3/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing fasting to no fasting before catheterisation laboratory procedures.
Scientific title
Safety and Care OF no Fasting prior to catheter laboratory procedures in Adults: a non-inferiority randomised control trial (SCOFF Trial)
Secondary ID [1] 308307 0
none
Universal Trial Number (UTN)
Trial acronym
SCOFF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheterisation Procedures 328092 0
Condition category
Condition code
Cardiovascular 325146 325146 0 0
Coronary heart disease
Cardiovascular 325147 325147 0 0
Other cardiovascular diseases
Anaesthesiology 325148 325148 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No fasting requirements of solids or liquids.
Patients in the interventional group are allowed to eat and drink as they please.
Patients will be questioned as to the last time of food and drink intake prior to the procedure.

This will be for pacemaker and defibrillator procedures as well as diagnostic and interventional cardiac angiography procedures.

Structural heart disease interventions, requirement for calcium modification therapy, electrophysiology studies and cardiac resynchronisation therapy procedures will be excluded
Intervention code [1] 324758 0
Treatment: Other
Comparator / control treatment
Solid food fasting for 6 hours prior to catheterisation laboratory procedure.
Clear liquid fasting for 2 hours prior to catheterisation laboratory procedure.

Patients will be questioned about last food and drink intake.
Control group
Active

Outcomes
Primary outcome [1] 332975 0
Composite primary endpoint of procedure related aspiration, hypotension, hyperglycaemia and hypoglycaemia.

Blood pressure measured by invasive catheterisation when available or non-invasive sphygmomanometer.
Blood sugar level (BSL) will be checked with a finger prick sample.
Aspiration pneumonia will be determined by clinician assessment in combination with chest radiography.
Timepoint [1] 332975 0
Follow-up until hospital discharge.
Secondary outcome [1] 415378 0
Mortality
Timepoint [1] 415378 0
30 days post procedure
Secondary outcome [2] 415379 0
Readmission collected via national stroke and readmission database.
Timepoint [2] 415379 0
30 days post procedure
Secondary outcome [3] 415380 0
Procedure related non-invasive ventilation (NIV) requirement.
Clinician assessment at the time of the procedure and review of medical records
Timepoint [3] 415380 0
Until discharge
Secondary outcome [4] 415381 0
Procedure related Intubation requirement based on clinician review and review of medical records.
Timepoint [4] 415381 0
Until discharge
Secondary outcome [5] 415382 0
Procedure related Acute Kidney Injury
Review of serology results on medical records.
Timepoint [5] 415382 0
72 hours post procedure
Secondary outcome [6] 415383 0
Patient reported satisfaction utilising the Popovich Preoperative Fasting Questionnaire.
Timepoint [6] 415383 0
Immediately post procedure
Secondary outcome [7] 415384 0
Health-related quality of life assessed using the EQ5D
Timepoint [7] 415384 0
Immediately post procedure
Secondary outcome [8] 415385 0
New ICU admission based on clinician review and electronic medical records.
Timepoint [8] 415385 0
Immediately post procedure

Eligibility
Key inclusion criteria
• Aged over 18 years of age.
• Are referred for catheterisation laboratory procedures including coronary angiography, percutaneous coronary intervention and device implantation or replacement (pacemakers and defibrillators).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant or breastfeeding females.
• Inability to provide informed consent.
• Requirement for a general anaesthetic.
• Complex catheterisation laboratory interventions
o Chronic total occlusion, rotational atherectomy, shockwave lithotripsy or planned mechanical support (IABP/Impella)
o Balloon aortic valvuloplasty, transcatheter aortic valve implantation, mitral valve clipping
o Electrophysiologic studies – diagnostic and ablation
o Biventricular Cardiac Resynchronisation Therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open label. Allocation is not concealed. Blinded endpoint adjudication committee.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Prospective, randomised, open label, blinded endpoint (PROBE) design
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/10/2022
Date of last participant enrolment
Anticipated
3/02/2024
Actual
14/09/2023
Date of last data collection
Anticipated
31/05/2024
Actual
23/10/2023
Sample size
Target
700
Accrual to date
Final
716
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23478 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 23479 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [3] 23480 0
Gosford Hospital - Gosford
Recruitment hospital [4] 24359 0
Belmont Hospital - Belmont
Recruitment hospital [5] 24360 0
The Maitland Hospital - Maitland
Recruitment hospital [6] 24361 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 38888 0
2250 - Gosford
Recruitment postcode(s) [2] 39943 0
2280 - Belmont
Recruitment postcode(s) [3] 39945 0
2298 - Waratah
Recruitment postcode(s) [4] 38886 0
2305 - New Lambton
Recruitment postcode(s) [5] 39944 0
2320 - Maitland
Recruitment postcode(s) [6] 38887 0
2340 - Tamworth

Funding & Sponsors
Funding source category [1] 312555 0
Hospital
Name [1] 312555 0
John Hunter Hospital
Country [1] 312555 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Road, New Lambton Heights New South Wales 2305
Country
Australia
Secondary sponsor category [1] 314159 0
None
Name [1] 314159 0
Address [1] 314159 0
Country [1] 314159 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311882 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 311882 0
Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 311882 0
Australia
Date submitted for ethics approval [1] 311882 0
22/03/2022
Approval date [1] 311882 0
30/08/2022
Ethics approval number [1] 311882 0

Summary
Brief summary
Fasting is standard of care prior to catheter laboratory procedures. The purpose of this is to reduce the risk of aspiration events during procedural sedation. Generally, this involves 6 hours of solid food fasting with 2 hours of clear fluid fasting.

Currently there are limited prospective data reviewing the utility of fasting versus no fasting prior to catheterisation procedures. Recently the CHOW NOW study based in America performed a randomised control trial assessing this question. They demonstrated non-inferiority of no-fasting with a pre-specified margin of 5.9%. We wish to assess the non-inferiority of no fasting for catheterisation laboratory procedures in a multicentre trial with a narrower non-inferiority margin of 3%.

Fasting prior to procedures may be associated with patient discomfort and distress. In addition, there are some populations where oral intake is important to prevent adverse events. Examples include those with chronic kidney disease where dehydration, potentially precipitated by fasting, associates with increased risk of contrast induced nephropathy. Moreover, patients are frequently cancelled due to lack of fasting. Relinquishing prerequisites for fasting prior to procedures may assist in providing expedited patient care and reduce adverse events related to underlying disease.

The main risk associated with no fasting is that of aspiration pneumonia. In the CHOW NOW study, only 0.7% of the non-fasting group experienced this adverse event. This is an uncommon and treatable complication. Risks of fasting (dehydration, hypotension, hypoglycaemia, contrast induced nephropathy, patient discomfort) may outweigh the benefits in preventing the uncommon event of aspiration pneumonia.
Though a randomised trial has already been performed, the American Society of Anaesthesiologists has requested more data prior to the acceptance of no fasting before simple catheterisation laboratory procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122710 0
Dr David Ferreira
Address 122710 0
Cardiovascular Department, John Hunter Hospital, Lookout Road, New Lambton Heights New South Wales 2305
Country 122710 0
Australia
Phone 122710 0
+61 02 4921 4200
Fax 122710 0
Email 122710 0
david.ferreira@health.nsw.gov.au
Contact person for public queries
Name 122711 0
Dr David Ferreira
Address 122711 0
Cardiovascular Department, John Hunter Hospital, Lookout Road, New Lambton Heights New South Wales 2305
Country 122711 0
Australia
Phone 122711 0
+61 02 4921 4200
Fax 122711 0
Email 122711 0
david.ferreira@health.nsw.gov.au
Contact person for scientific queries
Name 122712 0
Dr David Ferreira
Address 122712 0
Cardiovascular Department, John Hunter Hospital, Lookout Road, New Lambton Heights New South Wales 2305
Country 122712 0
Australia
Phone 122712 0
+61 02 4921 4200
Fax 122712 0
Email 122712 0
david.ferreira@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified patient data will be shared in entirety. This will include demographic data, serology results, primary and secondary outcomes, patient satisfaction and quality of life results as well as 30-day follow-up.
When will data be available (start and end dates)?
Available starting immediately post-trial cessation and ending 5 years post-trial cessation
Available to whom?
Reputable researchers with sound proposals.
Available for what types of analyses?
Any proposals deemed suitable by the steering committee.
How or where can data be obtained?
Contacting the PI: david.ferreira@health.nsw.gov.au


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
SourceTitleYear of PublicationDOI
Dimensions AISafety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial)2023https://doi.org/10.1093/ehjopen/oead111
N.B. These documents automatically identified may not have been verified by the study sponsor.