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Trial registered on ANZCTR
Registration number
ACTRN12619001548123
Ethics application status
Approved
Date submitted
22/10/2019
Date registered
11/11/2019
Date last updated
21/03/2022
Date data sharing statement initially provided
11/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Double NAC trial: Investigation of increased N-acetylcysteine dosing in patients treated for paracetamol overdose.
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Scientific title
Double NAC trial: Investigation of increased N-acetylcysteine dosing in patients treated for paracetamol overdose.
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Secondary ID [1]
297092
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
No
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Health condition
Health condition(s) or problem(s) studied:
paracetamol overdose
311103
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Condition category
Condition code
Injuries and Accidents
309735
309735
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0
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Poisoning
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
N-acetylcysteine (NAC) given intravenously 200mg/kg over 4 hours, followed by 200mg/kg over 16 hours
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Intervention code [1]
313363
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Treatment: Drugs
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Comparator / control treatment
N-acetylcysteine (NAC) given intravenously 200mg/kg over 4 hours, followed by 100mg/kg over 16 hours
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcomes will be the rate of “hepatic injury” (defined to be alanine transaminase (ALT) doubling and peak ALT >100IU/L measured at 20 hrs after the commencement of NAC infusion) and need for further antidote. ALT is assessed by serum assay. This is a composite primary outcome
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Assessment method [1]
318696
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Timepoint [1]
318696
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0 and 20 hours post initiation of NAC
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Secondary outcome [1]
365751
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These will include development of hepatotoxicity (defined as ALT >1000 IU/L). ALT measured by serum assay.
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Assessment method [1]
365751
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Timepoint [1]
365751
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0,20 hours post initiation and every 12 hrs till ALT peaked and downtrending
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Secondary outcome [2]
376328
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Peak INR>2. Measured by blood test.
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Assessment method [2]
376328
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Timepoint [2]
376328
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During hospital admission (up to 2 weeks)
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Secondary outcome [3]
376329
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Development of fulminant hepatic failure. Determined by bedside/clinical assessment.
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Assessment method [3]
376329
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Timepoint [3]
376329
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During hospital admission (up to 2 weeks)
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Secondary outcome [4]
376330
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Mortality. Determined by Bedside assessment.
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Assessment method [4]
376330
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Timepoint [4]
376330
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During hospital admission (anytime up to 4 weeks post admission)
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Secondary outcome [5]
376331
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Adverse reactions to N-acetylcysteine. These may include angioedema, rash, hypotension, vomiting, nausea, wheeze. Determined by clinical examination
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Assessment method [5]
376331
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Timepoint [5]
376331
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Up to 20 hours post initiation of N-acetylcysteine.
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Eligibility
Key inclusion criteria
Patients requiring NAC following single acute or staggered overdose with abnormal liver function tests on presentation (ALT>40 U/L), or paracetamol concentration more than double the nomogram treatment line, modified-release paracetamol paracetamol ingestions.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria will be patients who are pregnant, intoxicated or sedated patients with co-ingested alcohol or sedating drugs. Single acute overdose patients who are at low risk - normal ALT (<40 IU/L) and paracetamol concentrations less than double the nomogram treatment line will be excluded. Patients with an ALT >40 IU/L on admission and documented preexisting liver disease will be excluded.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/02/2020
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Actual
1/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
230
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Accrual to date
75
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
12908
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Dandenong Hospital - Dandenong
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Recruitment hospital [2]
12909
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [3]
12910
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Casey Hospital - Berwick
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Recruitment hospital [4]
12911
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [5]
12912
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Blacktown Hospital - Blacktown
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Recruitment hospital [6]
12914
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
25385
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3175 - Dandenong
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Recruitment postcode(s) [2]
25386
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3084 - Heidelberg
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Recruitment postcode(s) [3]
25387
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3806 - Berwick
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Recruitment postcode(s) [4]
25388
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3168 - Clayton
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Recruitment postcode(s) [5]
25389
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2148 - Blacktown
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Recruitment postcode(s) [6]
25391
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2145 - Westmead
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Funding & Sponsors
Funding source category [1]
301659
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Hospital
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Name [1]
301659
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Monash Health
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Address [1]
301659
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246 Clayton Road
Clayton
Victoria 3168
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Country [1]
301659
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Australia
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Primary sponsor type
Hospital
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Name
Monash Health
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Address
246 Clayton Road
Clayton
Victoria 3168
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Country
Australia
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Secondary sponsor category [1]
301372
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None
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Name [1]
301372
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Address [1]
301372
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Country [1]
301372
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302379
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Monash Health Human Research Ethics Committee
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Ethics committee address [1]
302379
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246 Clayton Road
Clayton
Victoria 3168
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Ethics committee country [1]
302379
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Australia
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Date submitted for ethics approval [1]
302379
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16/01/2019
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Approval date [1]
302379
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15/03/2019
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Ethics approval number [1]
302379
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Summary
Brief summary
Paracetamol is one of the most common medications taken in overdose around the world. It is readily available and does not require a prescription to purchase. N-acetylcysteine (NAC) is the antidote used to treat patients at risk of developing liver toxicity secondary to the metabolites of paracetamol that accumulate following paracetamol overdose. The standard NAC treatment regimen lasts 20 to 21 hours and requires admission to hospital.
Patients who present to hospital and receive NAC for paracetamol overdose and have normal liver function and subsequently have a less than therapeutic paracetamol concentration and normal liver function with at least 12 hours of treatment with NAC are unlikely to go on to develop liver toxicity.
Conversely, patients who present late (greater than 8 hours post ingestion) to hospital, or with abnormal liver function, high paracetamol concentration and require NAC treatment, are likely to require a prolonged course of treatment and might develop liver failure.
We aim to increase the dose of NAC in this high risk group and examine whether this decreases degree of liver injury and hospital length of stay.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
90026
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Dr Anselm Wong
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Address
90026
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Emergency Department
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Country
90026
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Australia
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Phone
90026
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+61 3 94965000
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Fax
90026
0
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Email
90026
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[email protected]
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Contact person for public queries
Name
90027
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Dr Anselm Wong
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Address
90027
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Emergency Department
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Country
90027
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Australia
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Phone
90027
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+61 3 94965000
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Fax
90027
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Email
90027
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[email protected]
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Contact person for scientific queries
Name
90028
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Dr Anselm Wong
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Address
90028
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Emergency Department
145 Austin Hospital
Studley Road
Heidelberg
Victoria 3084
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Country
90028
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Australia
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Phone
90028
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+61 3 94965000
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Fax
90028
0
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Email
90028
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
-
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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.
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