ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000407695

Ethics application status

Approved

Date submitted

9/04/2014

Date registered

15/04/2014

Date last updated

15/04/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

Use of acetylcysteine as an adjuvant treatment for patients with acute organophosphorus pesticides poisoning

Scientific title

In adult patients with acute organophosphorus pesticides poisoning could the use of N-acetylcysteine besides the standard treatment compared to the use of the standard treatment alone reduce mortality?

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1155-5041

Trial acronym

Linked study record

Health condition

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

acute organophosphorus pesticides poisoning

Condition category

Condition code

Injuries and Accidents

Poisoning

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

N-acetylcysteine will be given orally, as a dose of 600 mg three times daily for three days. If the patient vomits any dose within 1 hour of administration, the dose will be repeated.

Standard treatment: atropine administration (bolus dose of 2 to 5 mg IV, repeated every 10 to 15 minutes until dryness of bronchial secretions is clinically evident, then atropine injections will be given intermittently to patients as needed

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

standard treatment

Control group

Active

Outcomes

Primary outcome [1]

Mortality

Timepoint [1]

At one week after randomization

Secondary outcome [1]

Length of hospital stay

Timepoint [1]

At the time of discharge

Secondary outcome [2]

The total dose of atropine

Timepoint [2]

At the time of discharge

Eligibility

Key inclusion criteria

Patients (male or female, aged 18 years or older) with symptomatic acute OP poisoning (deliberate or accidental), with diagnosis made on the basis of the typical clinical toxidrome of cholinergic and nicotinic manifestations due to and following shortly after a single exposure to OP, besides reliable identification of the compound based on the container brought by patient attendants or a subsequent confirmation by pseudocholinesterase.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Patients who do not consent
- Patients less than 18 years of age
- Pregnant and lactating women
- Patients with ingestion or exposure to other substances in addition to the OP
- Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure)
- Patients presenting more than 12 hours of having consumed the OP compound (late presenters)

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/05/2014

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Emergency Hospital, Tanta University Hospitals

Address [1]

El-Gaish Street,Tanta University Hospitals, Tanta, Egypt

Country [1]

Egypt

Primary sponsor type

Individual

Name

Dr. Ahmad El-Ebiary

Address

Kafr-Esam Street, Medical Campus of Tanta University, Faculty of Medicine (Department of Forensic Medicine and Clinical Toxicology), Tanta, Egypt

Country

Egypt

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics Committee

Ethics committee address [1]

Kafr-Esam Street, Medical Campus of Tanta University, Faculty of Medicine (Quality Assurance Unit), Tanta, Egypt

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

27/03/2014

Approval date [1]

30/03/2014

Ethics approval number [1]

2457/03/14

Summary

Brief summary

This study will be carried out to evaluate the efficacy and safety of orally given acetylcysteine as an adjuvant treatment for adult patients with acute organophosphorus pesticide poisoning.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Ahmad El-Ebiary

Address

Kafr-Esam Street, Medical Campus of Tanta University, Faculty of Medicine (Department of Forensic Medicine and Clinical Toxicology), Tanta, Egypt

Country

Egypt

Phone

+2 010 61277577

Fax

[email protected]

Contact person for public queries

Name

Ahmad El-Ebiary

Address

Kafr-Esam Street, Medical Campus of Tanta University, Faculty of Medicine (Department of Forensic Medicine and Clinical Toxicology), Tanta, Egypt

Country

Egypt

Phone

+2 010 61277577

Fax

[email protected]

Contact person for scientific queries

Name

Ahmad El-Ebiary

Address

Kafr-Esam Street, Medical Campus of Tanta University, Faculty of Medicine (Department of Forensic Medicine and Clinical Toxicology), Tanta, Egypt

Country

Egypt

Phone

+2 010 61277577

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Organophosphorus poisoning is a major global healt... [More Details]
Study results article	Yes		Basic Clin Pharmacol Toxicol. 2016 Aug;119(2):222-... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	N-acetylcysteine in Acute Organophosphorus Pesticide Poisoning: A Randomized, Clinical Trial.	2016	https://dx.doi.org/10.1111/bcpt.12554

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

Trial Review

Documents added manually

Documents added automatically