Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001122640
Ethics application status
Approved
Date submitted
17/09/2023
Date registered
27/10/2023
Date last updated
27/10/2023
Date data sharing statement initially provided
27/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Point of care lactate testing for early paediatric sepsis recognition, antimicrobial administration, and management in the Emergency Department
Scientific title
Efficacy of point of care lactate testing for early paediatric sepsis recognition, antimicrobial administration, and management in the Emergency Department
Secondary ID [1] 310614 0
TBA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 331494 0
Paediatric Sepsis 331495 0
Condition category
Condition code
Emergency medicine 328230 328230 0 0
Resuscitation
Emergency medicine 328231 328231 0 0
Other emergency care
Infection 328317 328317 0 0
Other infectious diseases
Public Health 328318 328318 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will utilise fingerpick testing to obtain a blood sample (<0.6 microliters) from paediatric patients to conduct a Point of Care (PoC) lactate test. Lactate results are returned within 13 seconds, and documented within their medical record.

The PoC Lactate machine chosen is the NovaBiomedical Lactate Xpress Stat Strip Point of Care connectivity machine. It is a portable, single-operator handheld device requiring a whole blood sample of 0.6 microlitres to obtain a lactate result within 13 seconds, The machine is calibrated to return a lactate result from 0.3-20.0 mmol/L. These machines are presently endorsed by Queensland Health for use within other health care services throughout Queensland.

The test will be conducted by both registered nursing and medical clinicians from child participants who meet the screening eligibility criteria detailed on the Queensland Children’s Sepsis Pathway (QCSP) which is currently part of standard care. Children can be screened at any point during the patients journey (not just at Triage) within the Emergency Department (ED) with testing to occur when patients meet the outlined criteria. Upon returning a elevated lactate results (of >2mmol), Clinican’s will follow the QCSP to escalate care to the Senior Medical Officer (SMO) or Senior Registrar (SR) on shift for immediate review of the patient. Ongoing treatment will be at the discretion of the treating medical officer and will not be dictated by the PoC lactate result.

Phase One, Pre Intervention Cohort - Involves a medical chart audit of eligible participants admitted to Redcliffe Hospital during November 2023 - January 2024,.
Phase Two, Education and Consolidation - Involves a 3 month staff education (February 2024 - April 2024) on the PoC Lactate device and two month consolidation period (May 2024 - June 2024) of when the device will be utilised but patients will not be recruited into the study for analysis. This is to ensure that staff are confident in when and how to use the machine and to ascertain the independent influence of the machine’s integration into standard care, allowing for observation of the true impact of the intervention.
Phase Three - Post Intervention Group - Involves the prospective recruitment of participants for the implementation and use of the PoC Lactate machine over a three month period (July 2024 - September 2024) and data collection.
Intervention code [1] 327019 0
Early detection / Screening
Comparator / control treatment
In our Phase One 'pre intervention' cohort, standard care will be observed. Data will be audited for children who have been diagnosed with sepsis during Phase One (November 2023 - January 2024) and compared to the Phase Three post intervention group (July 2024 - September 2024) who have met criteria to receive the PoC Lactate test.
Control group
Historical

Outcomes
Primary outcome [1] 336096 0
Time to antibiotic administration is defined as the time from triage presentation to antibiotic administration.
Timepoint [1] 336096 0
From Triage presentation to administration of Intravenous Antibiotics (IVAB's).
Secondary outcome [1] 426828 0
Time of QCSP commencement to the time of SMO/SR review.
Timepoint [1] 426828 0
From QCSP commencement and SMO/SR review

Eligibility
Key inclusion criteria
To be eligible for the study, parent-child dyads must meet the following criteria. Patients need to be 17 years of age or younger with signs of an infective/viral illness and meet screening criteria for potential sepsis as outlined on the QCSP. These include:

Signs of infection, inclusive of history or evidence of fever or hypothermia, in addition to

(a) Looks sick/toxic

(b) Altered behaviour or altered level of consciousness (ALOC), defined by progressive lethargy, drowsiness or obtundation, restlessness and/or agitation and irritability/apnoeas in infants.

(c) Parental/guardian/clinician concern

(d) Re-presentation with the same illness

(e) Sepsis admission <30 days

(f) Aboriginal or Torres Strait Islander

(g) Immunocompromised

(h) Age <3 months
Minimum age
1 Hours
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Patients will be excluded from participation if:

(a) They present with altered Children’s Early Warning Tool scores due to trauma.

(b) They present with ALOC attributable to trauma.

(c) If consenting parents/guardians cannot read, write and/or understand English.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25532 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 41354 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 314827 0
Hospital
Name [1] 314827 0
Redcliffe Hospital (Redcliffe Private Practice Trust)
Country [1] 314827 0
Australia
Funding source category [2] 314828 0
Charities/Societies/Foundations
Name [2] 314828 0
Emergency Medicine Foundation
Country [2] 314828 0
Australia
Primary sponsor type
Hospital
Name
Redcliffe Hospital (Redcliffe Private Practice Trust)
Address
Redcliffe Hospital. Anzac Avenue, Redcliffe QLD 4020
Country
Australia
Secondary sponsor category [1] 316819 0
Charities/Societies/Foundations
Name [1] 316819 0
Emergency Medicine Foundation
Address [1] 316819 0
Suite 1B, Terraces, 19, Lang Parade, Milton QLD 4064
Country [1] 316819 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313833 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 313833 0
Human Research Ethics Committee Centre for Children’s Health Research Queensland Children’s Hospital Precinct Level 7, 62 Graham Street South Brisbane QLD 4101
Ethics committee country [1] 313833 0
Australia
Date submitted for ethics approval [1] 313833 0
31/05/2023
Approval date [1] 313833 0
01/06/2023
Ethics approval number [1] 313833 0
HREC/23/QCHQ 87189

Summary
Brief summary
This research will examine the impact of implementing a point of care (PoC) lactate machine on the administration of antibiotics in paediatric patients presenting with potential sepsis in the Emergency Department (ED). Elevated lactate levels are proven to be an accurate prognostic factor in predicting morbidity among patients with sepsis. Current practice requires that serum lactate samples are collected via intravenous cannulation or venepuncture, a distressing procedure for children and parents and challenging and time-consuming for staff . The PoC lactate machine is a portable, single-operator handheld device requiring finger prick blood sampling to obtain accurate lactate results. This negates the need for intravenous cannulation or venepuncture to obtain objective data to aid clinical decision-making. This may result in the earlier recognition of sepsis, administration of antibiotics and transfer to definitive care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129490 0
Ms Cassandra Ross
Address 129490 0
Emergency Services Complex - 125 Kedron Park Rd, Kedron QLD 4031
Country 129490 0
Australia
Phone 129490 0
+61 412435257
Fax 129490 0
Email 129490 0
cassandra.ross@health.qld.gov.au
Contact person for public queries
Name 129491 0
Ms Cassandra Ross
Address 129491 0
Emergency Services Complex - 125 Kedron Park Rd, Kedron QLD 4031
Country 129491 0
Australia
Phone 129491 0
+61 412435257
Fax 129491 0
Email 129491 0
cassandra.ross@health.qld.gov.au
Contact person for scientific queries
Name 129492 0
Ms Cassandra Ross
Address 129492 0
Emergency Services Complex - 125 Kedron Park Rd, Kedron QLD 4031
Country 129492 0
Australia
Phone 129492 0
+61 412435257
Fax 129492 0
Email 129492 0
cassandra.ross@health.qld.gov.au

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.