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Trial registered on ANZCTR
Registration number
ACTRN12617000018314
Ethics application status
Approved
Date submitted
22/12/2016
Date registered
5/01/2017
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of the usefulness of a new method for predicting the outcome of critical illness in patients admitted to intensive care.
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Scientific title
Evaluation of the utility of a new algorithm for the detection of the unmeasured ion excess in the human extracellular fluid for outcome prediction in critically ill intensive care patients.
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Secondary ID [1]
290802
0
Nil
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Universal Trial Number (UTN)
U1111-1191-1591
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Trial acronym
UNA UIX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical illness
301451
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Condition category
Condition code
Other
301172
301172
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Patients admitted to the intensive care unit will have the results from their routine daily blood tests entered into a new algorithm that is used to predict the presence of chemical species not normally seen in the blood of healthy people. The patients will be followed for seven days and their results will be examined for links to outcome which will be assessed by chart review at hospital discharge or death.
The algorithm (Unmeasured Ion eXcess - UIX) takes biochemical and acid-base data as its input and generates an output reporting the contribution of the input parameters as well as any unmeasured species to the overall acid-base status.
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Intervention code [1]
296719
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
300592
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In hospital mortality assessed by chart review
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Assessment method [1]
300592
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Timepoint [1]
300592
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Up to the time of death or discharge from hospital
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Secondary outcome [1]
330362
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Length of stay in ICU assessed by chart review
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Assessment method [1]
330362
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Timepoint [1]
330362
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Up to the time of discharge from the ICU
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Eligibility
Key inclusion criteria
All patients admitted to the ICU during the study period
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients under the age of 18 years
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
The overall ICU mortality rate is approximately 12% per annum with subgroups within that population rising to approximately 30% - an absolute difference of 18%. Detecting a conservative 10% difference in mortality with an alpha of 0.05 and a power of 0.80 requires a total sample size of 440. Based on recent data, a six month survey will capture 500 admissions.
General data descriptive methods will be employed - that is, mean (SD) for normally distributed data, median (IQR) for non-normal data and proportion (%) for categorical and binary data.
Comparisons will be performed using tests appropriate for the type of data. That is, the Students t-test will be used for normal data, the Wilcoxon rank sum test for non-normal data and chi-square and Fishers exact test for categorical/binary data.
Time to event data (eg: length of stay, mortality etc.) will be analysed using Cox proportional hazards modelling.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
6/02/2017
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Actual
12/05/2018
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Date of last participant enrolment
Anticipated
25/01/2019
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Actual
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Date of last data collection
Anticipated
31/01/2019
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Actual
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Sample size
Target
500
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Accrual to date
350
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
7173
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Nambour General Hospital - Nambour
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Recruitment hospital [2]
12692
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Sunshine Coast University Hospital - Birtinya
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Recruitment postcode(s) [1]
14934
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4560 - Nambour
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Recruitment postcode(s) [2]
25114
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4575 - Birtinya
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Funding & Sponsors
Funding source category [1]
295227
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Hospital
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Name [1]
295227
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Sunshine Coast University Hospital
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Address [1]
295227
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6 Doherty Street
Birtinya
QLD 4575
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Country [1]
295227
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Australia
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Primary sponsor type
Hospital
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Name
Sunshine Coast University Hospital
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Address
6 Doherty Street
Birtinya
QLD 4575
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Country
Australia
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Secondary sponsor category [1]
294056
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None
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Name [1]
294056
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Address [1]
294056
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Country [1]
294056
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296570
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The Prince Charles Hospital Human Research and Ethics Committee
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Ethics committee address [1]
296570
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The Prince Charles Hospital Building 14 Rode Road Chermside Queensland 4032
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Ethics committee country [1]
296570
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Australia
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Date submitted for ethics approval [1]
296570
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30/11/2016
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Approval date [1]
296570
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14/12/2016
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Ethics approval number [1]
296570
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HREC/16/QPCH/375
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Summary
Brief summary
It has been postulated that as a result of critical illness, patients leak particular chemicals from their cells with subsequent movement of these chemicals into the blood stream where they may be detected. Disappearance of these chemicals from the blood has been linked to resolution of the process that triggered the episode of critical illness and ultimately, to recovery of the patient. Currently and with few exceptions, direct measurement of these chemicals is not possible and their effect has to be inferred indirectly as part of another commonly performed measurement - the standard base excess (SBE). The SBE also responds to alterations in the concentrations of the major blood chemicals which are normally present in health. The changes in the normal chemistry of the blood occurs as a result of either the underlying critical illness or the fluids used during resuscitation and unfortunately, they also have a major effect on the SBE, The result is that the SBE becomes more of a general indicator of the presence of critical illness rather than a specific and sensitive predictor. It also can remain abnormal even when the patient has returned to health. A recent method for splitting the SBE into its components that permits the estimation of the specific effect of the unmeasured chemicals has been developed, published and experimentally validated - the Unmeasured Ion eXcess (UIX) algorithm. The utility of this algorithm needs to be formally tested in the clinical environment and it is this requirement that drives the need to conduct an audit that involves mapping the results of the routinely collected daily bloods in a population of critically ill patients to their eventual outcome and length of ICU and hospital stay.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
1343
1343
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/AnzctrAttachments/372068-Study Protocol v1.0 November 2016.pdf
(Protocol)
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Attachments [2]
1344
1344
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/AnzctrAttachments/372068-HREC 16-375 LNR Final approval 19 01 17.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
71330
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Dr Chris Anstey
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Address
71330
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c/- Intensive Care Unit
Nambour Hospital
Hospital Road
Nambour
QLD 4560
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Country
71330
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Australia
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Phone
71330
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+617 5470 6780
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Fax
71330
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+617 5470 6841
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Email
71330
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[email protected]
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Contact person for public queries
Name
71331
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Chris Anstey
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Address
71331
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c/- Intensive Care Unit
Nambour Hospital
Hospital Road
Nambour
QLD 4560
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Country
71331
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Australia
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Phone
71331
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+617 5470 6780
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Fax
71331
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+617 5470 6841
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Email
71331
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[email protected]
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Contact person for scientific queries
Name
71332
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Chris Anstey
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Address
71332
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c/- Intensive Care Unit
Nambour Hospital
Hospital Road
Nambour
QLD 4560
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Country
71332
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Australia
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Phone
71332
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+617 5470 6780
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Fax
71332
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+617 5470 6841
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Email
71332
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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