ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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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]

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

Condition category

Condition code

Other

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

In hospital mortality assessed by chart review

Timepoint [1]

Up to the time of death or discharge from hospital

Secondary outcome [1]

Length of stay in ICU assessed by chart review

Timepoint [1]

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?

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]

Nambour General Hospital - Nambour

Recruitment hospital [2]

Sunshine Coast University Hospital - Birtinya

Recruitment postcode(s) [1]

4560 - Nambour

Recruitment postcode(s) [2]

4575 - Birtinya

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sunshine Coast University Hospital

Address [1]

6 Doherty Street
Birtinya
QLD 4575

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sunshine Coast University Hospital

Address

6 Doherty Street
Birtinya
QLD 4575

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital Human Research and Ethics Committee

Ethics committee address [1]

The Prince Charles Hospital
Building 14
Rode Road
Chermside
Queensland
4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/11/2016

Approval date [1]

14/12/2016

Ethics approval number [1]

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]

/AnzctrAttachments/372068-Study Protocol v1.0 November 2016.pdf (Protocol)

Attachments [2]

/AnzctrAttachments/372068-HREC 16-375 LNR Final approval 19 01 17.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Chris Anstey

Address

c/- Intensive Care Unit
Nambour Hospital
Hospital Road
Nambour
QLD 4560

Country

Australia

Phone

+617 5470 6780

Fax

+617 5470 6841

chris.anstey@health.qld.gov.au

Contact person for public queries

Name

Chris Anstey

Address

c/- Intensive Care Unit
Nambour Hospital
Hospital Road
Nambour
QLD 4560

Country

Australia

Phone

+617 5470 6780

Fax

+617 5470 6841

chris.anstey@health.qld.gov.au

Contact person for scientific queries

Name

Chris Anstey

Address

c/- Intensive Care Unit
Nambour Hospital
Hospital Road
Nambour
QLD 4560

Country

Australia

Phone

+617 5470 6780

Fax

+617 5470 6841

chris.anstey@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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