ANZCTR - Registration

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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

2/08/2024

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]

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

Novel Psychoactive Substances use

Drug-related harms

Condition category

Condition code

Emergency medicine

Other emergency care

Public Health

Epidemiology

Public Health

Health promotion/education

Public Health

Health service research

Public Health

Other public health

Injuries and Accidents

Poisoning

Mental Health

Addiction

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Early Detection / Screening

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Type of illicit drug(s) detected in patient blood sample.

Timepoint [1]

Blood sample collected as soon as possible after arrival at the emergency department.

Primary outcome [2]

Type of novel psychoactive substance(s) detected in patient blood sample.

Timepoint [2]

Blood sample collected as soon as possible after arrival at the emergency department.

Secondary outcome [1]

Concentration of illicit drug(s) detected in patient blood sample.

Timepoint [1]

Blood sample collected as soon as possible after arrival at the emergency department.

Secondary outcome [2]

Concentration of novel psychoactive substance(s) detected in patient blood sample.

Timepoint [2]

Blood sample collected as soon as possible after arrival at the emergency department.

Secondary outcome [3]

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]

Clinical information will be collected retrospectively from medical records within one month of the patient's presentation.

Secondary outcome [4]

Length of stay in the emergency department (in minutes).

Timepoint [4]

Collected retrospectively from medical records (discharge summary) within one month of the patient's presentation.

Secondary outcome [5]

Length of stay in the intensive care unit (in minutes).

Timepoint [5]

Collected retrospectively from medical records (discharge summary) within one month of the patient's presentation.

Secondary outcome [6]

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]

Collected retrospectively from medical records (discharge summary) within one month of the patient's presentation.

Secondary outcome [7]

Blood alcohol concentration (two decimal places).

Timepoint [7]

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?

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]

Royal Perth Hospital - Perth

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [3]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [4]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [5]

Royal Hobart Hospital - Hobart

Recruitment hospital [6]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

6000 - Perth

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

5000 - Adelaide

Recruitment postcode(s) [4]

4102 - Woolloongabba

Recruitment postcode(s) [5]

7000 - Hobart

Recruitment postcode(s) [6]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

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]

Hospital

Name [1]

East Metropolitan Health Service

Address [1]

Royal Perth Hospital
10 Murray Street
Perth WA 6000

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Curtin University - Health Research and Data Analytics Hub

Address [1]

Kent Street,
Bentley WA 6102

Country [1]

Australia

Other collaborator category [2]

Other Collaborative groups

Name [2]

ChemCentre WA

Address [2]

Curtin University
Building 500
Corner Manning Road & Townsing Drive
Bentley WA 6102

Country [2]

Australia

Other collaborator category [3]

Other Collaborative groups

Name [3]

Forensic Science South Australia

Address [3]

21 Divett Place,
Adelaide SA 5000

Country [3]

Australia

Other collaborator category [4]

Other Collaborative groups

Name [4]

Victorian Institute of Forensic Medicine

Address [4]

65 Kavanagh Street,
Southbank VIC 3006

Country [4]

Australia

Other collaborator category [5]

Other Collaborative groups

Name [5]

NSW Health Pathology

Address [5]

45 Watt Street,
Newcastle, NSW 2323

Country [5]

Australia

Other collaborator category [6]

Other Collaborative groups

Name [6]

Forensic Science Service Tasmania

Address [6]

20 St Johns Avenue,
New Town TAS 7008

Country [6]

Australia

Other collaborator category [7]

Other Collaborative groups

Name [7]

Forensic and Scientific Services - Queensland Health

Address [7]

39 Kessels Road
Coopers Plains QLD 4018

Country [7]

Australia

Other collaborator category [8]

Other Collaborative groups

Name [8]

National Centre for Clinical Research on Emerging Drugs (NCCRED)

Address [8]

University of New South Wales
Sydney NSW 2052

Country [8]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service Human Research Ethics Committee

Ethics committee address [1]

Level 2, Southern Research Facility (Perkins building) 
Fiona Stanley Hospital, 11 Robin Warren Drive, MURDOCH WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2019

Approval date [1]

11/12/2019

Ethics approval number [1]

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

Prof Daniel Fatovich

Address

Emergency Department
Royal Perth Hospital
GPO Box X2213
Perth WA 6847

Country

Australia

Phone

+61892242662

Fax

[email protected]

Contact person for public queries

Name

Jennifer Smith

Address

RPH Research Foundation
50 Murray St, PERTH WA 6000

Country

Australia

Phone

+61 0433583873

Fax

[email protected]

Contact person for scientific queries

Name

Daniel Fatovich

Address

Emergency Department
Royal Perth Hospital
GPO Box X2213
Perth WA 6847

Country

Australia

Phone

+61892242662

Fax

[email protected]

Data sharing statement

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

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.	Type	Citation	Link	Email	Other Details	Attachment
10772	Ethical approval					381446-(Uploaded-16-04-2021-15-38-34)-Study-related document.pdf
10773	Study 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

Source	Title	Year of Publication	DOI
Embase	A cluster of acute thebaine poisonings from non-food grade poppy seeds in the Australian food supply.	2023	https://dx.doi.org/10.1080/15563650.2023.2265053

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically