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Trial registered on ANZCTR


Registration number
ACTRN12617000334303p
Ethics application status
Not yet submitted
Date submitted
1/03/2017
Date registered
3/03/2017
Date last updated
3/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does application of the sepsis scoring system qSOFA and early notification to senior medical staff in a Remote Australian Emergency Department improve the outcomes of patients presenting with sepsis
Scientific title
Does application of the sepsis scoring system qSOFA and early notification to senior medical staff in a Remote Australian Emergency Department improve the outcomes of patients presenting with sepsis
Secondary ID [1] 291327 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 302308 0
Condition category
Condition code
Infection 301892 301892 0 0
Studies of infection and infectious agents
Public Health 301898 301898 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Introduction of a 'code sepsis' at first presentation to ED triage at Alice Springs Emergency Department.
A triage nurse trained and experienced in the use of the Australian Triage Score and qSOFA (quick sequential organ function assessment) will assess the likelihood of an infection being present and measure the parameters in qSOFA. If the patient has a clinical suspicion of infection and scores 1 or more on qSOFA a sepsis page will alert a medical officer.
qSOFA is a bedside clinical score calculated using physiological parameters (blood pressure, respiratory rate) and clinical assessment of conscious level to provide a risk assessment of the likelihood of having or developing severe sepsis and septic shock.
Block quasi-randomisation will be used on a week on week off basis with group one having clinical assessment (90% centile within 10minutes) and group two a clinical assessment (90% centile within 10minutes) and point of care lactate (serum blood test performed on analyser within the Emergency Department 90% centile within 10minutes from the time of triage).
End points measured will be antibiotic rates, time to antibiotics and validation of the sensitivity of qSOFA with and without the addition of point of care lactate in a remote and mainly Indigenous ED population
length of stay, rates and timing of ICU admission and mortality will be reported but this study is not expected to be powered sufficiently to detect a significant difference in these parameters
Adherence to the protocol will be monitored and updates and education as well as recruitment figures supplied to triage and medical staff at weekly education meetings
Intervention code [1] 297355 0
Early detection / Screening
Intervention code [2] 297356 0
Diagnosis / Prognosis
Comparator / control treatment
Retrospective case note review will be used to validate qSOFA in the population presenting to Alice Springs emergency department as well as compare historical times to antibiotics. Comparison will also be made with other commonly used sepsis scoring systems (SIRS, LODS) and the locally developed early warning score to be used in Remote health nurse led clinics in Central Australia; Remote Early Warning Score (REWS)
The historical control group will be identified by case note review of patients presented with suspected sepsis between January 2016 and December 2016 inclusive.
SIRS/LODS and REWS for the intervention group participants will be calculated from retrospective case notes review by the investigators, not calculated at the time of triage to reduce the workload burden on the triage staff
Control group
Historical

Outcomes
Primary outcome [1] 301320 0
Time for the presentation to triage at the ED to the administration of antibiotics for patients presenting to the Alice Springs emergency department with suspected sepsis assessed by retrospective case note review
Timepoint [1] 301320 0
At the time of antibiotic administration
Primary outcome [2] 301321 0
Proportion of participants receiving antibiotics within 1 hour post presentation to ED, compared between group one (no point of care lactate) and group two (point of care lactate), assessed by retrospective case note review
Timepoint [2] 301321 0
At the time of antibiotic administration
Secondary outcome [1] 332294 0
Validation of the qSOFA score by calculation of sensitivity and specificity and assessed by comparison with SIRS/LODS/REWS scores for sepsis in a remote and mainly Indigenous Australian population presenting to Alice Springs Emergency Department with a clinical suspicion of sepsis
Timepoint [1] 332294 0
retrospective case notes review and review of prospective cases at the time of discharge
Secondary outcome [2] 332295 0
length of stay in hospital assessed by retrospective case note review
Timepoint [2] 332295 0
Measured at the time of discharge
Secondary outcome [3] 332296 0
admission rates to ICU within 48hrs of the time of triage assessed by retrospective case note review
Timepoint [3] 332296 0
48hrs from the time of triage
Secondary outcome [4] 332297 0
Rates of antibiotic use in the Emergency Department at Alice Springs Hospital prior to admission to the ward or discharge assessed by retrospective case note review
Timepoint [4] 332297 0
measured at the time of admission by an in-patient specialist team or discharge from the emergency department

Eligibility
Key inclusion criteria
All non-pregnant patients over the age of 18years presenting to the Emergency Department at Alice Springs Hospital with a clinical suspicion of infection and scoring at lease 1 on the qSOFA score
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with long term cognitive inability to give consent and those under guardianship

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation on a week on, week off basis for pragmatic considerations
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To show reduction in the time to antibiotics to below 1hr from the current median of >2hrs (case note review) in the block randomised prospective component of the study at alpha of 0.05 and beta of 0.2 we require 63 patients in each group
To show an increase of antibiotic use within 1 hour (evidence of clinician suspicion of sepsis) of 10% following a raised point of care lactate result with alpha of 0.05, beta of 0.2, q1 and 2 of 0.5 each and effect size of 0.2 we require 393 patients in each group assuming a positive lactate rate of 40% in patients with +ve qSOFA (case note review)
Statistical analysis of the block randomised groups to assess the change in time to antibiotics and lactate effect will be using Student's two-tailed t test
Validation and comparison of qSOFA/SIRS?LODS REWS will use area under the receiver operating curve

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
Date of last participant enrolment
Anticipated
30/11/2017
Actual
Date of last data collection
Anticipated
15/12/2017
Actual
Sample size
Target
786
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 7590 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 15488 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 295790 0
Hospital
Name [1] 295790 0
Alice Springs Hospital
Country [1] 295790 0
Australia
Primary sponsor type
Individual
Name
Samuel Goodwin
Address
Director of Medical and Clinical Services
Alice Springs Hospital
Gap Road
Alice Springs, NT
0870
Country
Australia
Secondary sponsor category [1] 294639 0
None
Name [1] 294639 0
Address [1] 294639 0
Country [1] 294639 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297087 0
Central Australian Human Research Ethics Committee
Ethics committee address [1] 297087 0
CAHREC
Centre for Remote Health
cnr Simpson and Skinner Sts
ALICE SPRINGS
NT 0870
Ethics committee country [1] 297087 0
Australia
Date submitted for ethics approval [1] 297087 0
22/03/2017
Approval date [1] 297087 0
Ethics approval number [1] 297087 0

Summary
Brief summary
In order to validate the sepsis-3 quick Sequential Organ Dysfunction Assessment (qSOFA) score in a remote ED population and setting, it will be compared retrospectively by case note review against the Systemic Inflammatory Response Syndrome (SIRS), Remote Early Warning Score (REWS) and Medical Emergency Warning Score (MEWS) for rates of Intensive Care Unit/High Dependency Unit (ICU/HDU) admission and in-hospital mortality.
A prospective introduction of the qSOFA score with and without point of care lactate as an early warning tool at the first point of contact with ASH ED triage and its use as an alert for early senior medical staff involvement, will attempt identify the most efficient way to shorten the time to treatment of patients with severe infections.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1545 1545 0 0
/AnzctrAttachments/372469-DRAFT ethics application.docx

Contacts
Principal investigator
Name 72934 0
Dr Richard Johnson
Address 72934 0
Alice Springs Emergency Department
Alice Springs Hospital
Gap Road
NT 0870
Country 72934 0
Australia
Phone 72934 0
+61 0889517657
Fax 72934 0
Email 72934 0
[email protected]
Contact person for public queries
Name 72935 0
Richard Johnson
Address 72935 0
Alice Springs Emergency Department
Alice Springs Hospital
Gap Road
NT 0870
Country 72935 0
Australia
Phone 72935 0
+61 0889517657
Fax 72935 0
Email 72935 0
[email protected]
Contact person for scientific queries
Name 72936 0
Richard Johnson
Address 72936 0
Alice Springs Emergency Department
Alice Springs Hospital
Gap Road
NT 0870
Country 72936 0
Australia
Phone 72936 0
+61 0889517657
Fax 72936 0
Email 72936 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23497Study protocol-999999  

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo 372469-(Uploaded-06-10-2019-04-13-13)-Other results publication.pdf

Documents added automatically
No additional documents have been identified.