Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001234808
Ethics application status
Approved
Date submitted
16/04/2021
Date registered
13/09/2021
Date last updated
9/09/2022
Date data sharing statement initially provided
13/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emerging Drugs Network of Australia: a toxicosurveillance system of illicit and emerging drugs in the Emergency Department
Scientific title
Emerging Drugs Network of Australia: a national multi-centre prospective toxicosurveillance system of illicit and emerging drugs detected in emergency department presentations
Secondary ID [1] 303944 0
Nil
Universal Trial Number (UTN)
U1111-1264-9899
Trial acronym
EDNA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Illicit Drug Use 320794 0
Novel Psychoactive Substances use 320795 0
Drug-related harms 321580 0
Condition category
Condition code
Emergency medicine 318615 318615 0 0
Other emergency care
Public Health 318616 318616 0 0
Epidemiology
Public Health 318617 318617 0 0
Health promotion/education
Public Health 318618 318618 0 0
Health service research
Public Health 318619 318619 0 0
Other public health
Injuries and Accidents 319319 319319 0 0
Poisoning
Mental Health 320441 320441 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Weeks
Description of intervention(s) / exposure
EDNA is a national multi-centre prospective toxicosurveillance system of acute illicit drug-related presentations to emergency departments. The following sentinel hospitals and partner forensic laboratories will contribute clinical and toxicological data to the EDNA National Clinical Registry, hosted at Curtin University.
Sites:
• New South Wales: Liverpool Hospital and NSW Health Pathology
• Queensland: Princess Alexandra Hospital and Forensic & Scientific Services
• South Australia: Royal Adelaide Hospital and Forensic Science SA
• Tasmania: Royal Hobart Hospital and Forensic Science Service Tasmania
• Victoria: Austin Health and Victorian Institute of Forensic Medicine
• Western Australia: Royal Perth Hospital and ChemCentre WA

Patient Population:
Patients presenting with severe and/or unusual clinical features associated with stimulant, hallucinogenic or opioid poisoning, and /or patients presenting as part of a suspected cluster of poisonings, and where a blood test and/or intravenous cannulation is required as part of usual care, will be sought for inclusion into the registry. Patients will be excluded from the registry if intravenous access is not required as part of usual care, or if the treating clinician considers symptoms are predominantly related to causes other than acute illicit drug effects (e.g. pure alcohol intoxication).

Data Collection:
The EDNA Clinical Registry will include de-identified clinical and toxicological data on eligible patients presenting to sentinel sites. The scope of data collected and dataset specifications will align with a minimum dataset endorsed by the EDNA National Steering Committee.
Toxicological data
Uniform mechanisms to collect and store blood samples from eligible patients, and analytical testing methods conducted by partner forensic laboratory, will enable precise identification of the substances causing acute toxicity.
A single blood sample (4ml EDTA blood tube) will be collected as soon as possible after arrival at the emergency department by the treating physician or a qualified clinical staff member (e.g. clinical nurse). Samples are immediately stored at -20°C onsite, or transported to the relevant laboratory for appropriate storage and analysis.
Clinical data
Clinical information relating to the current episode of acute toxicity will be collected retrospectively from patient medical records within one month of the patient’s presentation. Key clinical data elements collected include:
• ED presentation details: triage date/time; age; sex; mode of arrival; Australasian triage scale;
• Drug exposure: reported drug exposure; setting of drug use; known regular medications;
• First recorded observations (pre-hospital or at hospital)
• Clinical complications related to drug exposure in first 24 hours of acute toxicity (pre-hospital or at hospital);
• Patient management / treatment provided by pre-hospital and acute hospital staff
• Patient outcomes (ED/hospital disposition; ED/ICU/hospital length of stay)

Duration of observation: observational data will be collected from the point of first recorded contact with ambulance services in the pre-hospital environment or from the time of ED presentation (hospital) to the time at which a patient disposition status related to the current episode of care can be reasonably ascertained from the medical record.

All data entered into the clinical registry will be permanently de-identified, therefore no follow up observations will be possible.
Intervention code [1] 319768 0
Early Detection / Screening
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326613 0
Type of illicit drug(s) detected in patient blood sample.
Timepoint [1] 326613 0
Blood sample collected as soon as possible after arrival at the emergency department.
Primary outcome [2] 326614 0
Type of novel psychoactive substance(s) detected in patient blood sample.
Timepoint [2] 326614 0
Blood sample collected as soon as possible after arrival at the emergency department.
Secondary outcome [1] 398373 0
Concentration of illicit drug(s) detected in patient blood sample.
Timepoint [1] 398373 0
Blood sample collected as soon as possible after arrival at the emergency department.
Secondary outcome [2] 398374 0
Concentration of novel psychoactive substance(s) detected in patient blood sample.
Timepoint [2] 398374 0
Blood sample collected as soon as possible after arrival at the emergency department.
Secondary outcome [3] 398375 0
Clinical complications related to drug exposure. This is a composite secondary outcome. Presence of the following pre-determined clinical parameters will be recorded:

Hyperthermia (greater than or equal to 38°C)
Disseminated intravascular coagulation
Hypothermia (less than or equal to 35°C)
Tachycardia (HR greater than or equal to 100bpm)
Bradycardia (HR less than or equal to 60bpm)
Arrhythmia
Cardiac Arrest
Hypertension (SBP greater than or equal to 160mmHg)
Hypotension (SBP less than or equal to 90mmHg)
Hyperventilation (RR greater than or equal to 30brpm)
Hypoventilation (RR less than or equal to 6brpm)
Apnoea
Minimum GCS eye score
Minimum GCS verbal score
Minimum GCS motor score
Minimum GCS total score
Seizure
Clonus (if yes, specify number of beats)
Vomiting
Diarrhoea
Urinary retention
Abnormal sweating
Dystonia
Hypertonia
Hyperreflexia
Acute kidney injury (peak creatinine greater than or equal to 1.5 x baseline OR if baseline level not available, peak level greater than or equal to 120µmol/L males and greater than or equal to 100µmol females)
Acute liver injury (ALT greater than or equal to 1000)
Rhabdomyolysis (CK greater than or equal to 1000)
Aspiration pneumonia/pneumonitis
Hypoxic brain injury
Persistent psychotic symptoms greater than or equal to 24 hrs (hallucinations, delusions, paranoia)
Other Complication (specify)
Timepoint [3] 398375 0
Clinical information will be collected retrospectively from medical records within one month of the patient's presentation.
Secondary outcome [4] 400185 0
Length of stay in the emergency department (in minutes).
Timepoint [4] 400185 0
Collected retrospectively from medical records (discharge summary) within one month of the patient's presentation.
Secondary outcome [5] 400186 0
Length of stay in the intensive care unit (in minutes).
Timepoint [5] 400186 0
Collected retrospectively from medical records (discharge summary) within one month of the patient's presentation.
Secondary outcome [6] 400187 0
Patient disposition from the emergency department. This is a composite secondary outcome. Patient disposition will be reported as one of the following pre-determined options:

Short stay or observation ward
ICU
General hospital ward
Psychiatry ward / Mental Health Unit
Discharge home
Discharge against medical advice
Transferred to other hospital/institution
Transferred to external psychiatric facility
Police custody
Deceased
Other (specify)
Unknown
Timepoint [6] 400187 0
Collected retrospectively from medical records (discharge summary) within one month of the patient's presentation.
Secondary outcome [7] 400200 0
Blood alcohol concentration (two decimal places).
Timepoint [7] 400200 0
First result recorded after arrival at the emergency department.

Eligibility
Key inclusion criteria
Inclusion Criteria:
Clinical features of severe illicit drug intoxication include:

1. Stimulant toxicity (sympathomimetic, serotonergic or anticholinergic toxicity)
- Patients requiring intravenous sedation for manifestations of toxicity;
- Patients with illness critical enough to require ICU level care.

2. Hallucinogenic toxicity
- Patients requiring intravenous sedation for manifestations of toxicity;
- Patients with illness critical enough to require ICU level care.

3. Opioid toxicity
- Patients requiring a large initial dose of naloxone (e.g. >400microgram in first hour);
- Patients requiring multiple repeat doses or an infusion of naloxone;
- Patients with illness critical enough to require ICU level care.

4. Other
Additional suggestive features of drug toxicity will be sought to determine eligibility, including reports of recreational drug use by the patient or collaterals (i.e. family, friends, witnesses, police, ambulance), presentation from a public event (e.g. festival or concert) and/or multiple patients from the same location presenting with similar clinical features.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with clinically mild drug toxicity, or where intravenous access is not required;

2. Patients presenting with agitation that is considered by the clinician to be predominantly related to methamphetamine-induced psychosis, without significant physiologic manifestations suggestive of acute drug intoxication;

3. Patients under the age of 16 years.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Initial reporting cycles and analyses will be predominantly descriptive, including tabulating demographic characteristics of our population (age and sex) and for specific drugs. This will also enable reporting of key outputs such as the number and type of new NPS identified from toxicological analyses (including quantitative blood levels).

Geographical and time trends in drugs identified will be examined annually to identify evolving changes. Patterns in clinical features (eg. hyperthermia, blood pressure), specific aspects of clinical management (eg. use of sedation) and patient outcomes (eg. discharged home, admitted to ICU, death) will be explored between drug groups using chi-square test or Fisher’s exact test (dichotomous variables) or logistic regression (continuous variables) to identify potential associations. Examination of outcomes will also enable us to determine resource implications for different drugs, such as length of stay (LOS) in ED and LOS in hospital, using truncated negative binomial regression.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/04/2020
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
5000
Accrual to date
850
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 18783 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 18789 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 18802 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 18803 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 18806 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 19997 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 34705 0
2170 - Liverpool
Recruitment postcode(s) [2] 33236 0
3084 - Heidelberg
Recruitment postcode(s) [3] 33250 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 33249 0
5000 - Adelaide
Recruitment postcode(s) [5] 33230 0
6000 - Perth
Recruitment postcode(s) [6] 33253 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 307894 0
Government body
Name [1] 307894 0
National Health and Medical Research Council
Country [1] 307894 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Harry Perkins Institute of Medical Research
Address
Fiona Stanley Hospital
5 Robin Warren Drive,
Murdoch, WA 6150
Country
Australia
Secondary sponsor category [1] 310142 0
Hospital
Name [1] 310142 0
East Metropolitan Health Service
Address [1] 310142 0
Royal Perth Hospital
10 Murray Street
Perth WA 6000
Country [1] 310142 0
Australia
Other collaborator category [1] 281659 0
University
Name [1] 281659 0
Curtin University - Health Research and Data Analytics Hub
Address [1] 281659 0
Kent Street,
Bentley WA 6102
Country [1] 281659 0
Australia
Other collaborator category [2] 281744 0
Other Collaborative groups
Name [2] 281744 0
ChemCentre WA
Address [2] 281744 0
Curtin University
Building 500
Corner Manning Road & Townsing Drive
Bentley WA 6102
Country [2] 281744 0
Australia
Other collaborator category [3] 281745 0
Other Collaborative groups
Name [3] 281745 0
Forensic Science South Australia
Address [3] 281745 0
21 Divett Place,
Adelaide SA 5000
Country [3] 281745 0
Australia
Other collaborator category [4] 281746 0
Other Collaborative groups
Name [4] 281746 0
Victorian Institute of Forensic Medicine
Address [4] 281746 0
65 Kavanagh Street,
Southbank VIC 3006
Country [4] 281746 0
Australia
Other collaborator category [5] 281747 0
Other Collaborative groups
Name [5] 281747 0
NSW Health Pathology
Address [5] 281747 0
45 Watt Street,
Newcastle, NSW 2323
Country [5] 281747 0
Australia
Other collaborator category [6] 281748 0
Other Collaborative groups
Name [6] 281748 0
Forensic Science Service Tasmania
Address [6] 281748 0
20 St Johns Avenue,
New Town TAS 7008
Country [6] 281748 0
Australia
Other collaborator category [7] 281749 0
Other Collaborative groups
Name [7] 281749 0
Forensic and Scientific Services - Queensland Health
Address [7] 281749 0
39 Kessels Road
Coopers Plains QLD 4018
Country [7] 281749 0
Australia
Other collaborator category [8] 281955 0
Other Collaborative groups
Name [8] 281955 0
National Centre for Clinical Research on Emerging Drugs (NCCRED)
Address [8] 281955 0
University of New South Wales
Sydney NSW 2052
Country [8] 281955 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307892 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 307892 0
Level 2, Southern Research Facility (Perkins building)
Fiona Stanley Hospital, 11 Robin Warren Drive, MURDOCH WA 6150
Ethics committee country [1] 307892 0
Australia
Date submitted for ethics approval [1] 307892 0
21/11/2019
Approval date [1] 307892 0
11/12/2019
Ethics approval number [1] 307892 0
RGS0000003673

Summary
Brief summary
The unprecedented rise in synthetic drugs, many containing unknown toxic agents, has made timely analytical diagnosis more difficult, and has reduced the confidence of clinicians providing Emergency Department (ED) management to this population of patients. This has also impacted the quality of evidence informing harm reduction responses. The Emerging Drugs Network of Australia (EDNA) brings together emergency physicians, toxicologists and forensic laboratories to establish a national system of surveillance and reporting of illicit and emerging drugs causing acute toxicity.

EDNA will improve coordination between clinicians and analytical services by way of its standardised approach to surveillance and reporting. Blood analysis of intoxicated patients will be conducted by forensic laboratories to enable precise identification of the substances causing acute toxicity. This will be linked with clinical data collected at the time of ED presentation to enable analysis of the clinical effects and outcomes associated with different illicit and emerging drugs.

Standardisation of data collection recorded in a national clinical registry will provide more robust data on epidemiology and associated harms. This will facilitate the translation of clinical and toxicological
evidence into timely, appropriate harm reduction and policy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108842 0
Prof Daniel Fatovich
Address 108842 0
Emergency Department
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 108842 0
Australia
Phone 108842 0
+61892242662
Fax 108842 0
Email 108842 0
daniel.fatovich@health.wa.gov.au
Contact person for public queries
Name 108843 0
Dr Jennifer Smith
Address 108843 0
Centre for Clinical Research in Emergency Medicine
Royal Perth Hospital
Level 6, Q Block, Wellington Street, PERTH, WA, 6000
Country 108843 0
Australia
Phone 108843 0
+61 0433583873
Fax 108843 0
Email 108843 0
jennifer.smith4@health.wa.gov.au
Contact person for scientific queries
Name 108844 0
Prof Daniel Fatovich
Address 108844 0
Emergency Department
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 108844 0
Australia
Phone 108844 0
+61892242662
Fax 108844 0
Email 108844 0
daniel.fatovich@health.wa.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
All data transferred, stored and made available for analysis and reporting from the EDNA National Clinical Registry will be supported by strict policies governing de-identification processes, data storage and access permissions. This national surveillance system will have capacity to identify the illicit and emerging drugs causing greatest harm, and enable trends in use and clinical effects to be reported over-time. For these purposes, data will be collated and analysed as group data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10772Ethical approval    381446-(Uploaded-16-04-2021-15-38-34)-Study-related document.pdf
10773Study protocol    381446-(Uploaded-16-04-2021-15-39-48)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA cluster of acute thebaine poisonings from non-food grade poppy seeds in the Australian food supply.2023https://dx.doi.org/10.1080/15563650.2023.2265053
N.B. These documents automatically identified may not have been verified by the study sponsor.