Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001622190
Ethics application status
Approved
Date submitted
13/11/2019
Date registered
22/11/2019
Date last updated
15/09/2020
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
What are the levels of ketone bodies in adult patients who are fasting for either elective or emergency surgeries in an Australian tertiary hospital?
Scientific title
A prospective observational study to quantify the extent of ketonaemia in fasting adult patients undergoing elective and emergency surgeries at an Australian tertiary hospital (KETO Study)
Secondary ID [1] 299860 0
None
Universal Trial Number (UTN)
U1111-1243-5532
Trial acronym
KETO study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ketoacidosis 315180 0
starvation ketosis 315181 0
Condition category
Condition code
Anaesthesiology 313498 313498 0 0
Anaesthetics
Metabolic and Endocrine 313565 313565 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients who are fasting for surgery will have preoperative blood ketone level measured. The blood sample is taken immediately prior to commencement of surgery. All patients will also have blood ketone level measured immediately at the end of surgery. Other information collected are risk factors (e.g. fasting duration, comorbidities, diet, pregnancy status), blood glucose, HbA1c and venous blood gas for patients found to have above-normal ketone level.
Intervention code [1] 316063 0
Diagnosis / Prognosis
Intervention code [2] 316064 0
Early Detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321956 0
Quantification of the extent of preoperative ketonaemia in fasting adult surgical patients undergoing elective and emergency surgeries. This is measured via a point-of-care blood ketone meter using small blood sample.
Timepoint [1] 321956 0
Immediately before commencement of surgery.
Secondary outcome [1] 376795 0
Acid-base status as assessed by blood gas analysis in subgroup of patients found to have preoperative blood ketone level of 0.6 mmol/L or above.
Timepoint [1] 376795 0
Immediately before surgery.
Secondary outcome [2] 376796 0
Postoperative ketonaemia in fasting adult surgical patients undergoing elective and emergency surgeries. This is measured via a point-of-care blood ketone meter using small blood sample.
Timepoint [2] 376796 0
Immediately at the end of surgery
Secondary outcome [3] 377043 0
Acid-base status as assessed by blood gas analysis in subgroup of patients found to have preoperative blood ketone level of 0.6 mmol/L or above.
Timepoint [3] 377043 0
Immediately at the end of surgery

Eligibility
Key inclusion criteria
Adult patients > 18 years of age
American Society of Anaesthesiologist (ASA) physical scale 1-4
Elective or emergency surgeries under general anaesthesia OR local/regional anaesthesia when the patient is fasted preoperatively.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent
People whose primary language is other than English
Emergency surgeries of very high urgency such that the time needed to obtain consent for study could, in study team’s opinion, affect clinical outcome

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In the only English-language observational study of preoperative blood ketone level to date, the prevalence of hyperketonaemia is 3% (3 out of 100), one of which was a patient who was on ketogenic diet. Due to the small sample size no clear relationship between blood ketone level and various risk factors were observed. There is no other English literature on the prevalence of hyperketonaemia and its risk factors, therefore the sample size of 1000 is arrived at to achieve reasonable number of detected cases of around 30 (assuming similar prevalence of 3%) to enable higher statistical power to identify predictors of hyperketonaemia, and to stay within feasibility of patient recruitment in this institution.

The analysis and reporting of the results will follow CONSORT guidelines. Baseline characteristics will be tabulated using appropriate summary statistics.

The extent of ketonaemia will be described by summary statistics and descriptive charts including box plot, scatterplots and histogram as appropriate. The prevalence of “hyperketonaemia” using threshold of BOHB >1.0 mmol/L will be calculated.

The secondary objectives (relationship between hyperketonaemia and risk factors) will be explored by multiple linear regression and multiple logistic regression models. Correction for multiple comparisons will be made in the calculation of statistical significance. If a risk factor is found to be significant in logistic regression models, the odds ratio will be presented with its 95% confidence interval.

In all analyses, the significance level to be used is a = 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/11/2019
Actual
16/03/2020
Date of last participant enrolment
Anticipated
30/11/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
1000
Accrual to date
105
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15143 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 28439 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 304268 0
Hospital
Name [1] 304268 0
Royal Perth Hospital
Country [1] 304268 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
197 Wellington Street, Perth, WA, 6000
Country
Australia
Secondary sponsor category [1] 304512 0
None
Name [1] 304512 0
Address [1] 304512 0
Country [1] 304512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304725 0
East Metropolitan Health Service
Ethics committee address [1] 304725 0
Ethics committee country [1] 304725 0
Australia
Date submitted for ethics approval [1] 304725 0
22/10/2019
Approval date [1] 304725 0
20/01/2020
Ethics approval number [1] 304725 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98006 0
Dr Chang Yang Yew
Address 98006 0
Royal Perth Hospital, 197 Wellington Street, Perth, WA, 6000
Country 98006 0
Australia
Phone 98006 0
+61892241036
Fax 98006 0
Email 98006 0
[email protected]
Contact person for public queries
Name 98007 0
Chang Yang Yew
Address 98007 0
Royal Perth Hospital, 197 Wellington Street, Perth, WA, 6000
Country 98007 0
Australia
Phone 98007 0
+61892241036
Fax 98007 0
Email 98007 0
[email protected]
Contact person for scientific queries
Name 98008 0
Chang Yang Yew
Address 98008 0
Royal Perth Hospital, 197 Wellington Street, Perth, WA, 6000
Country 98008 0
Australia
Phone 98008 0
+61892241036
Fax 98008 0
Email 98008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.