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Trial registered on ANZCTR


Registration number
ACTRN12616001457437
Ethics application status
Approved
Date submitted
2/10/2016
Date registered
19/10/2016
Date last updated
10/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The demographic factors associated with blood ketone levels in acute care patients.
Scientific title
An observational study of the demographic factors, blood chemistry and clinical observations associated with blood ketone levels in acute care patients during hospital admission.
Secondary ID [1] 290178 0
None
Universal Trial Number (UTN)
U1111-1187-8136
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perioperative nutritional status 300321 0
Blood ketone levels 300487 0
Condition category
Condition code
Diet and Nutrition 300189 300189 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A single blood ketone level will be measured using a drop of blood discarded during cannulation or incidental to other blood tests during acute inpatient care.
Intervention code [1] 295938 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299672 0
Blood ketone level measured with point of care StatStrip Xpress Meter.
Timepoint [1] 299672 0
At time of cannualtion or blood sampling for other investigations.
Secondary outcome [1] 327783 0
Nutritional status [Body Mass Index, history of weight loss, fasting time] extracted from the patient's electronic medical record. [compound endpoint].
Timepoint [1] 327783 0
As near as possible to time of the blood ketone measurement..
Secondary outcome [2] 327784 0
Blood creatinine extracted from the patient's electronic medical record.
Timepoint [2] 327784 0
As near as possible to the blood ketone measurement.
Secondary outcome [3] 327785 0
Patient demographics listed in the patient electronic medical record. [age, gender, type of admission, ICU care, surgical procedures, length of stay, mode of separation]. [compound endpoint].
Timepoint [3] 327785 0
On discharge from hospital.
Secondary outcome [4] 328123 0
Comorbidities [diabetes, pregnancy, respiratory support] extracted from the patient's electronic medical record. [compound endpoint].
Timepoint [4] 328123 0
As near as possible to the blood ketone measurement.
Secondary outcome [5] 328281 0
Blood electrolytes, extracted from the patient's electronic medical record.
Timepoint [5] 328281 0
As near as possible to the blood ketone measurement
Secondary outcome [6] 328282 0
Haemaglobin, white cell count and platelet count extracted from the patient's electronic medical record. [composite outcome]
Timepoint [6] 328282 0
As near as possible to the blood ketone measurement.
Secondary outcome [7] 328283 0
Blood glucose extracted from the patient's electronic medical record.
Timepoint [7] 328283 0
As near as possible to the blood ketone measurement.

Eligibility
Key inclusion criteria
Patients attending hospital for acute inpatient care. They will be a sample of convenience selected from surgical, intensive care and emergency department attendances.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that are not already having blood tests or cannulation.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Using a sample of 500 tests will permit subgroup analysis to identify associations with a range of demographic factors. No hypotheses are being tested so a power analysis is not relevant in this setting. Regression, correlation and multiple logistic regression will be used to assess these associations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2016
Actual
14/06/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
500
Accrual to date
63
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6758 0
St George Hospital - Kogarah
Recruitment hospital [2] 6759 0
Shoalhaven Hospital - Nowra
Recruitment postcode(s) [1] 14403 0
2217 - Kogarah
Recruitment postcode(s) [2] 14404 0
2541 - Nowra

Funding & Sponsors
Funding source category [1] 294622 0
Hospital
Name [1] 294622 0
St. George Hospital Department of Anaesthesia
Country [1] 294622 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia - St. George Hospital
Address
Gray St. Kogarah, NSW 2217
Country
Australia
Secondary sponsor category [1] 293484 0
None
Name [1] 293484 0
Address [1] 293484 0
Country [1] 293484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296063 0
South Eastern Sydney LHD Human Research Ethics Committee
Ethics committee address [1] 296063 0
POWH, High St. Randwick, NSW, 2031
Ethics committee country [1] 296063 0
Australia
Date submitted for ethics approval [1] 296063 0
04/10/2016
Approval date [1] 296063 0
13/04/2017
Ethics approval number [1] 296063 0
16/097

Summary
Brief summary
Blood ketone measurement has been used in the treatment of diabetic ketoacidosis for some time. However it also provides a monitor of nutritional status. Ketonaemia [elevated blood ketones] occur when the body switches from glucose to fatty acids as the main metabolic substrate. This occurs in starvation, during illness and also with prolonged perioperative fasting. The aim of this study is to establish the prevalence and associations of ketonaemia in acute care patients.
Point of care, single drop, blood analysis [similar to blood sugar testing] provides a simple method of detecting ketonaemia. Making measurements on discarded blood during cannulation or routine blood collection and relating the ketone level to factors collected from the electronic medical record [eMR] will enable normal ranges and demographic associations to be established. This observational study will permit use of blood ketone measurement to detect nutritionally vulnerable populations and establish a baseline for studies of specific interventions in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69126 0
A/Prof Richard Morris
Address 69126 0
St. George Hospital
Gray St.
Kogarah NSW 2217
Country 69126 0
Australia
Phone 69126 0
+61 2 91132100
Fax 69126 0
Email 69126 0
[email protected]
Contact person for public queries
Name 69127 0
Richard Morris
Address 69127 0
St. George Hospital
Gray St.
Kogarah NSW 2217
Country 69127 0
Australia
Phone 69127 0
+61 2 91132100
Fax 69127 0
Email 69127 0
[email protected]
Contact person for scientific queries
Name 69128 0
Richard Morris
Address 69128 0
St. George Hospital
Gray St.
Kogarah NSW 2217
Country 69128 0
Australia
Phone 69128 0
+61 2 91132100
Fax 69128 0
Email 69128 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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