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Trial registered on ANZCTR


Registration number
ACTRN12612001229864
Ethics application status
Approved
Date submitted
19/11/2012
Date registered
21/11/2012
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Tissue oxygenation in early sepsis study
Scientific title
Tissue oxygen saturation as predictor of
organ dysfunction in Emergency Department patients with Sepsis
Secondary ID [1] 281564 0
None
Universal Trial Number (UTN)
Trial acronym
Assessing risk in sepsis using tissue oxygen saturation (ARISTOS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 287846 0
Condition category
Condition code
Infection 288195 288195 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Tissue oxygen saturation (StO2) will be measured non-invasively in the muscles of the hand using near infrared spectroscopy. This gives an estimate of the adequacy of the circulation and may be an early indicator of developing shock. These measurements take a few seconds to perform and will be taken on initial assessment in the Emergency Department and three hours subsequently in patients presenting to the Emergency Department with infections. The aim is to evaluate if StO2 is useful to identify patients who are at risk of deteriorating and developing organ failure in the subsequent days following admission to hospital.
Intervention code [1] 286086 0
Not applicable
Comparator / control treatment
Observational study.
All participants will have tissue oxygen saturation measurements and be followed for outcome.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288393 0
Organ failure defined using sequential organ failure assessment (SOFA) score of 2 or more points increase from baseline
Timepoint [1] 288393 0
Once daily SOFA score up to 72 hours following admission from Emergency Department or discharge/death if earlier
Primary outcome [2] 288394 0
Peak, mean and delta (maximal change from admission) SOFA score
Timepoint [2] 288394 0
Once daily SOFA score up to 72 hours following admission from Emergency Department or discharge/death if earlier
Secondary outcome [1] 300038 0
Death (all cause) as determined from hospital patient database (which is updated from the state register of Births, Deaths and marriages) hospital medical records or contact with the patients primary care doctor as necessary.
Timepoint [1] 300038 0
28 days
Secondary outcome [2] 300039 0
Subgroup analysis of organ failure (SOFA score of 2 or more) developing among patients with no organ failure or shock present at enrolment
Timepoint [2] 300039 0
Once daily SOFA score up to 72 hours following admission from Emergency Department or discharge/death if earlier
Secondary outcome [3] 300040 0
Subgroup analysis of peak, mean and delta SOFA score among patients with organ failure/shock present at enrolment
Timepoint [3] 300040 0
Once daily SOFA score up to 72 hours following admission from Emergency Department or discharge/death if earlier

Eligibility
Key inclusion criteria
Suspected or proven infection plus 2 or more of (i) temperature >38 of <36 degrees celsius (ii) heart rate >90bpm (iii) respiratory rate >20/min (iv) total white blood count >12x109/L or <4x109/L, and being admitted to hospital for intravenous antibiotics.

Patients will be included if they meet criteria for uncomplicated sepsis, severe sepsis (associated with organ dysfunction) and/or septic shock. Criteria for severe sepsis or septic shock as follows:

Case definition for sepsis as above PLUS either -
1. Organ failure defined as SOFA score of 2 or more e.g. acute respiratory failure, renal failure, or altered mental state
2. Shock defined as (a)systolic blood pressure (SBP) <90mmHg, or mean arterial pressure (MAP)<65mmHg or heart rate >SBP (shock index >1) despite 20-30ml/kg isotonic fluid bolus or (b) serum lactate >4mmol/L.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <18 years
Expected to die from other cause (e.g. malignancy) within 90 days
Diagnosed significant chronic cognitive impairment (MMSE<21)
Not for resuscitation order
Intravenous antibiotics prior to presentation

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 5067 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [2] 5068 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 5069 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 286348 0
Hospital
Name [1] 286348 0
Armadale Health Service
Address [1] 286348 0
PO Box 460
Armadale WA 6992
Country [1] 286348 0
Australia
Funding source category [2] 286349 0
Hospital
Name [2] 286349 0
Royal Perth Hospital
Address [2] 286349 0
GPO Box 2213
Perth WA 6000
Country [2] 286349 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 285137 0
None
Name [1] 285137 0
Address [1] 285137 0
Country [1] 285137 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288429 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 288429 0
Fremantle Hospital
PO Box 480
Fremantle
WA 6959
Ethics committee country [1] 288429 0
Australia
Date submitted for ethics approval [1] 288429 0
20/06/2012
Approval date [1] 288429 0
16/10/2012
Ethics approval number [1] 288429 0
1/12/0241

Summary
Brief summary
Severe sepsis accounts for significant morbidity and mortality in the community and is a large contributor to healthcare costs. The hallmark of severe sepsis is organ failure or shock. Patients with community acquired sepsis are initially assessed in the Emergency Department (ED). The signs of early organ dysfunction or shock may not be present when the patient is seen in in the ED, leading to delayed treatment and increased costs.

This study will investigate a new technique to measure tissue oxygenation (StO2) non-invasively called near-infrared spectroscopy (NIRS) using a commercially available device. StO2 is a measure of impaired circulation and may be an early indicator of developing shock. We will measure StO2 in the ED in patients who are being admitted to hospital with sepsis. The study hypothesis is that StO2 is associated with organ failure and so can be used to identify patients at risk in this setting.

We aim to recruit 300 patients presenting to two metropolitan Emergency departments in Western Australia during this study.

This study is investigator initiated and has been designed and funded independently from the manufacturer of the NIRS device or any other industry sponsor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34969 0
Dr Stephen Macdonald
Address 34969 0
Centre for Clinical research in Emergency Medicine
Harry Perkins Institute of Medical Research
Royal Perth Hospital
GPO Box X2213
Perth WA 6000
Country 34969 0
Australia
Phone 34969 0
+61 8 9224 8458
Fax 34969 0
Email 34969 0
stephen.macdonald@health.wa.gov.au
Contact person for public queries
Name 18216 0
Dr Dr Stephen Macdonald
Address 18216 0
Emergency Medicine
University of Western Australia, Armadale Health Service
PO Box 460
Armadale WA 6992
Country 18216 0
Australia
Phone 18216 0
+61 8 9391 2599
Fax 18216 0
Email 18216 0
stephen.macdonald@health.wa.gov.au
Contact person for scientific queries
Name 9144 0
Dr Dr Stephen Macdonald
Address 9144 0
Emergency Medicine
University of Western Australia, Armadale Health Service
PO Box 460
Armadale WA 6992
Country 9144 0
Australia
Phone 9144 0
+61 8 9391 2599
Fax 9144 0
Email 9144 0
stephen.macdonald@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary