RecruitingACTRN12621001234808

Emerging Drugs Network of Australia: a toxicosurveillance system of illicit and emerging drugs in the Emergency Department

Emerging Drugs Network of Australia: a national multi-centre prospective toxicosurveillance system of illicit and emerging drugs detected in emergency department presentations

Sponsor

Harry Perkins Institute of Medical Research

Enrollment

6,000 participants

Start Date

Apr 11, 2020

Study Type

Observational

Conditions

Novel Psychoactive Substances use Illicit Drug Use Drug-related harms

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.

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

The rise of synthetic and novel illicit drugs has made it increasingly hard for emergency doctors to know exactly what substance a patient has taken — and therefore how to treat them safely. This national surveillance project called EDNA (Emerging Drugs Network of Australia) is bringing together emergency physicians, toxicologists, and forensic laboratories to create a standardised system for identifying these substances through blood tests and linking the results to patient outcomes. When someone presents to an Emergency Department with severe drug toxicity — such as extreme agitation requiring sedation, opioid overdose requiring repeated antidote doses, or serious organ effects — blood samples will be taken and analysed by forensic labs to precisely identify what drug caused the reaction. This will help doctors understand the effects and dangers of different drugs, and support better harm reduction policies. This study is for people aged 16 or older who present to a participating Emergency Department with severe illicit drug toxicity requiring intravenous treatment or intensive care. People with mild drug toxicity or purely behavioural presentations without significant physical effects are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.