ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000973314

Ethics application status

Approved

Date submitted

23/06/2017

Date registered

6/07/2017

Date last updated

13/07/2021

Date data sharing statement initially provided

14/02/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Efficacy of a two bag N-acetylcysteine(NAC) regimen to treat paracetamol overdose (2NAC study).

Scientific title

Efficacy of a two bag N-acetylcysteine(NAC) regimen to treat paracetamol overdose (2NAC study)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

2 NAC study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

paracetamol overdose

Condition category

Condition code

Mental Health

Suicide

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Acetylcysteine intravenously (200mg/kg over 4 hours followed immediately by 100mg/kg over 16 h0urs)

For patients requiring treatment with antidote post paracetamol overdose.

Intervention code [1]

Not applicable

Comparator / control treatment

Acetylcysteine intravenously (150 mg/kg over 0.25 to 1 hour, 50 mg/kg over 4 hours, 100mg/kg over 16 hours)

For patients requiring treatment with antidote post paracetamol overdose.

Historical control: Between 1980 and 2005 - Canadian Acetaminophen Overdose Study

Control group

Historical

Outcomes

Primary outcome [1]

The primary outcome will be the rate of acute liver injury (defined as peak Alanine transaminase (ALT)>150 IU/L and double baseline) stratified by time to first presentation bloods (<8 hrs or >8hrs). This will be assessed using serum samples.

Timepoint [1]

During hospital admission.

Secondary outcome [1]

Development of hepatotoxicity (alanine transaminase:ALT > 1000 IU/L). This will be assessed using serum samples.

Timepoint [1]

During hospital admission

Eligibility

Key inclusion criteria

All paracetamol overdose treated with acetylcysteine

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

No treatment with acetylcysteine or overdose of paracetamol.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

Descriptive data and proportions will be used in the study. Means (95%CI) or median (IQR) will be reported and the student t-test or the Mann Whitney U test will be used to analyze unpaired continuous data as indicated. The Chi square will be used to analyse unpaired categorical data.
Statistical significance will be recognized at <0.05.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

1/02/2014

Date of last participant enrolment

Anticipated

1/06/2022

Actual

Date of last data collection

Anticipated

1/06/2022

Actual

Sample size

Target

3000

Accrual to date

2600

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [3]

Casey Hospital - Berwick

Recruitment hospital [4]

Dandenong Hospital - Dandenong

Recruitment hospital [5]

Prince of Wales Hospital - Randwick

Recruitment hospital [6]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [7]

Calvary Mater Newcastle - Waratah

Recruitment hospital [8]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [9]

Westmead Hospital - Westmead

Recruitment hospital [10]

Blacktown Hospital - Blacktown

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3168 - Clayton

Recruitment postcode(s) [3]

3806 - Berwick

Recruitment postcode(s) [4]

3175 - Dandenong

Recruitment postcode(s) [5]

2031 - Randwick

Recruitment postcode(s) [6]

4102 - Woolloongabba

Recruitment postcode(s) [7]

2298 - Waratah

Recruitment postcode(s) [8]

2050 - Camperdown

Recruitment postcode(s) [9]

2145 - Westmead

Recruitment postcode(s) [10]

2148 - Blacktown

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Health

Address [1]

Clayton Road, Clayton, Victoria 3168

Country [1]

Australia

Primary sponsor type

Hospital

Name

Monash Health

Address

Clayton Road, Clayton, Victoria 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health HREC

Ethics committee address [1]

Clayton Road, Clayton, Victoria 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/04/2017

Ethics approval number [1]

Summary

Brief summary

Paracetamol overdose is the most common pharmaceutical poisoning in developed countries and its incidence is increasing in the developing world. Overdose can lead to liver failure, and in the worst circumstances, death. In overdose, the increased production of N-acetyl para-benzoquinoneimine (NAPQI) depletes hepatic glutathione stores and eventually causes hepatocyte injury. Acetylcysteine is administered as the antidote to prevent hepatotoxicity in overdose. The typical three-bag infusion-dosing regimen in Australia is 150 mg/kg over 1 hour, 50 mg/kg over 4 hours and 100 mg/kg over 16 hours.
Despite the safety of this regimen, there remains a significant amount of adverse reactions to acetylcysteine and delays between infusions. To this effect, a recent study of over 200 patients who received a two-bag acetylcysteine regimen was recently undertaken. A 200mg/kg loading dose of NAC was infused over four hours with a further 100 mg/kg infused over 16-hours. The incidence and severity of adverse reactions was significantly reduced, compared to the three-bag regimen, from 10% to 4.3%. A similar two-bag regimen has been adopted by various hospitals around Australia. 

The efficacy of this new two-bag regimen has not been determined. We aim to compare the rate of acute liver injury using a two-bag acetylcysteine regimen and compare this to the three-bag regimen in the setting of paracetamol overdose.

Trial website

Trial related presentations / publications

Public notes

Ethics obtained from Feb 2014 from Monash Health to 24/4/17. Multicentre study approved thereafter.

Contacts

Principal investigator

Name

Dr Anselm Wong

Address

c/o Emergency Department
Austin Health
Heidelberg 3084
Victoria

Country

Australia

Phone

+61 394965000

Fax

anselm.wong@austin.org.au

Contact person for public queries

Name

Anselm Wong

Address

c/o Emergency Department
Austin Health
Heidelberg 3084
Victoria

Country

Australia

Phone

+61 394965000

Fax

anselm.wong@austin.org.au

Contact person for scientific queries

Name

Anselm Wong

Address

c/o Emergency Department
Austin Health
Heidelberg 3084
Victoria

Country

Australia

Phone

+61 394965000

Fax

anselm.wong@austin.org.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

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.

Trial Review

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