Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001240831
Ethics application status
Approved
Date submitted
1/11/2012
Date registered
23/11/2012
Date last updated
9/01/2023
Date data sharing statement initially provided
14/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian TOxicology Monitoring(ATOM) Study: The pharmacokinetics and pharmacodynamics of drugs in overdose
Scientific title
Australian TOxicology Monitoring(ATOM) Study: The pharmacokinetics and pharmacodynamics of drugs in overdose
Secondary ID [1] 281488 0
Nil
Universal Trial Number (UTN)
Trial acronym
ATOM study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drugs in overdose 287754 0
Condition category
Condition code
Other 288094 288094 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is looking at the pharmacokinetics and pharmacodynamics of various drugs in overdose.
It is not an interventional study.
The aim of this research project is to study the clinical pharmacology of a number of new drugs, by modelling their concentrations and clinical effects from data collected from overdose patients.
Participants will be selected by the Prince of Wales Toxicology unit, either by the Clinical Toxicologist or Toxicology Fellow.
Drugs of interest that will be studied include any newly marketed drugs, rare but serious overdoses such as colchicine, analgesics such as paracetamol and antipsychotics.
Data collected on these partcipants include drug and dose ingested, any symptoms, ECG data, drug and metabolite levels.
The study will run for 5 years
Intervention code [1] 285998 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288298 0
Pharmacokinetics of various drugs in overdose - by measuring concentrations of the drug or its metabolite in serum and or urine.
Timepoint [1] 288298 0
Standard treatment in patients, whom take an overdose of a medication, depends on the drug ingested. The majority of patient's whom take an overdose will have an ECG and bloods taken on arrival to the emergency department. Then depending on the drug ingested, severity of the overdose and response to treatment, the patient may require additional ECG's and blood tests. The number and timing of these investigations depends on the drug ingested and the patients clinical condition. The Toxicologist on duty will determine how many blood samples will need to be collected.
Hence timepoints for data collection depends on the drug ingested, its half life, if its a sustained release product and the clinical condition of the patient.
Primary outcome [2] 288299 0
Pharmacodynamics:determine the relationship between drug concentration and clinical effects.
For the study, it is intended to employ a population analysis technique that is reliant on recording relatively sparse data obtained in drug overdose circumstances. The modelling will require the sequential collection of drug concentrations, ECG parameters (e.g. QT interval) and the tracking of associated clinical effects, including the occurrence of arrhythmias and seizures
Timepoint [2] 288299 0
The number and timing of these investigations depends on the drug ingested and the patients clinical condition. The Toxicologist on duty will determine how many blood samples will need to be collected.
Hence timepoints for data collection depends on the drug ingested, its half life, if its a sustained release product and the clinical condition of the patient.
Secondary outcome [1] 299782 0
nil
Timepoint [1] 299782 0
nil

Eligibility
Key inclusion criteria
Overdose in the past 24 hours with a drug
Minimum age
14 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In custody
less than 14 years

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2012
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
1000
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7472 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 7473 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 7474 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 7475 0
Westmead Hospital - Westmead
Recruitment hospital [5] 7476 0
Blacktown Hospital - Blacktown
Recruitment hospital [6] 7477 0
Sydney Children's Hospital - Randwick
Recruitment hospital [7] 7478 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 7479 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [9] 15886 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 15301 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 15302 0
2298 - Waratah
Recruitment postcode(s) [3] 29343 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 286260 0
Hospital
Name [1] 286260 0
Prince of Wales Hospital
Country [1] 286260 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Clinical Toxicology Unit
POWH
Barker Street Randwick 2031
NSW
Country
Australia
Secondary sponsor category [1] 285060 0
None
Name [1] 285060 0
Address [1] 285060 0
Country [1] 285060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288336 0
South Eastern Sydney Local Health District HREC - southern sector
Ethics committee address [1] 288336 0
Ethics committee country [1] 288336 0
Australia
Date submitted for ethics approval [1] 288336 0
Approval date [1] 288336 0
05/10/2012
Ethics approval number [1] 288336 0
1/12/0067

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34911 0
Dr Angela Chiew
Address 34911 0
Department of Clinical Toxicology
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 34911 0
Australia
Phone 34911 0
+61 9382 8400
Fax 34911 0
+61 2 60160860
Email 34911 0
[email protected]
Contact person for public queries
Name 18158 0
Angela Chiew
Address 18158 0
Prince of Wales Hospital
Emergency Department
Barker Street
Randwick, NSW 2031
Country 18158 0
Australia
Phone 18158 0
+61 2 9382 4269
Fax 18158 0
Email 18158 0
[email protected]
Contact person for scientific queries
Name 9086 0
Angela Chiew
Address 9086 0
Prince of Wales Hospital
Emergency Department
Barker Street
Randwick, NSW 2031
Country 9086 0
Australia
Phone 9086 0
+61 2 9382 4269
Fax 9086 0
Email 9086 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6918Study protocol    363233-(Uploaded-07-02-2020-09-33-06)-Study-related document.pdf
6919Ethical approval    363233-(Uploaded-03-02-2020-10-37-13)-Study-related document.pdf
6920Informed consent form    363233-(Uploaded-03-02-2020-10-36-55)-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
EmbaseModified release paracetamol overdose: a prospective observational study (ATOM-3).2018https://dx.doi.org/10.1080/15563650.2018.1439950
EmbaseEarly acetaminophen-protein adducts predict hepatotoxicity following overdose (ATOM-5).2020https://dx.doi.org/10.1016/j.jhep.2019.10.030
N.B. These documents automatically identified may not have been verified by the study sponsor.