Trial Review

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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.
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.
Secondary ID [1] 290802 0
Nil
Universal Trial Number (UTN)
U1111-1191-1591
Trial acronym
UNA UIX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 301451 0
Condition category
Condition code
Other 301172 301172 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 296719 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300592 0
In hospital mortality assessed by chart review
Timepoint [1] 300592 0
Up to the time of death or discharge from hospital
Secondary outcome [1] 330362 0
Length of stay in ICU assessed by chart review
Timepoint [1] 330362 0
Up to the time of discharge from the ICU

Eligibility
Key inclusion criteria
All patients admitted to the ICU during the study period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under the age of 18 years

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/02/2017
Actual
12/05/2018
Date of last participant enrolment
Anticipated
25/01/2019
Actual
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
500
Accrual to date
350
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7173 0
Nambour General Hospital - Nambour
Recruitment hospital [2] 12692 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 14934 0
4560 - Nambour
Recruitment postcode(s) [2] 25114 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 295227 0
Hospital
Name [1] 295227 0
Sunshine Coast University Hospital
Country [1] 295227 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast University Hospital
Address
6 Doherty Street
Birtinya
QLD 4575
Country
Australia
Secondary sponsor category [1] 294056 0
None
Name [1] 294056 0
Address [1] 294056 0
Country [1] 294056 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296570 0
The Prince Charles Hospital Human Research and Ethics Committee
Ethics committee address [1] 296570 0
The Prince Charles Hospital
Building 14
Rode Road
Chermside
Queensland
4032
Ethics committee country [1] 296570 0
Australia
Date submitted for ethics approval [1] 296570 0
30/11/2016
Approval date [1] 296570 0
14/12/2016
Ethics approval number [1] 296570 0
HREC/16/QPCH/375

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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1343 1343 0 0
/AnzctrAttachments/372068-Study Protocol v1.0 November 2016.pdf (Protocol)
Attachments [2] 1344 1344 0 0
/AnzctrAttachments/372068-HREC 16-375 LNR Final approval 19 01 17.pdf (Ethics approval)

Contacts
Principal investigator
Name 71330 0
Dr Chris Anstey
Address 71330 0
c/- Intensive Care Unit
Nambour Hospital
Hospital Road
Nambour
QLD 4560
Country 71330 0
Australia
Phone 71330 0
+617 5470 6780
Fax 71330 0
+617 5470 6841
Email 71330 0
[email protected]
Contact person for public queries
Name 71331 0
Dr Chris Anstey
Address 71331 0
c/- Intensive Care Unit
Nambour Hospital
Hospital Road
Nambour
QLD 4560
Country 71331 0
Australia
Phone 71331 0
+617 5470 6780
Fax 71331 0
+617 5470 6841
Email 71331 0
[email protected]
Contact person for scientific queries
Name 71332 0
Dr Chris Anstey
Address 71332 0
c/- Intensive Care Unit
Nambour Hospital
Hospital Road
Nambour
QLD 4560
Country 71332 0
Australia
Phone 71332 0
+617 5470 6780
Fax 71332 0
+617 5470 6841
Email 71332 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.