Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 284408 0
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 291601 0
Condition category
Condition code
Injuries and Accidents 291979 291979 0 0
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] 289149 0
Treatment: Drugs
Comparator / control treatment
standard treatment
Control group
Active

Outcomes
Primary outcome [1] 291880 0
Mortality
Timepoint [1] 291880 0
At one week after randomization
Secondary outcome [1] 307727 0
Length of hospital stay
Timepoint [1] 307727 0
At the time of discharge
Secondary outcome [2] 307728 0
The total dose of atropine
Timepoint [2] 307728 0
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?
No
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
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5976 0
Egypt
State/province [1] 5976 0

Funding & Sponsors
Funding source category [1] 289055 0
Hospital
Name [1] 289055 0
The Emergency Hospital, Tanta University Hospitals
Country [1] 289055 0
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] 287723 0
None
Name [1] 287723 0
Address [1] 287723 0
Country [1] 287723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290852 0
Research Ethics Committee
Ethics committee address [1] 290852 0
Kafr-Esam Street, Medical Campus of Tanta University, Faculty of Medicine (Quality Assurance Unit), Tanta, Egypt
Ethics committee country [1] 290852 0
Egypt
Date submitted for ethics approval [1] 290852 0
27/03/2014
Approval date [1] 290852 0
30/03/2014
Ethics approval number [1] 290852 0
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 47598 0
A/Prof Ahmad El-Ebiary
Address 47598 0
Kafr-Esam Street, Medical Campus of Tanta University, Faculty of Medicine (Department of Forensic Medicine and Clinical Toxicology), Tanta, Egypt
Country 47598 0
Egypt
Phone 47598 0
+2 010 61277577
Fax 47598 0
Email 47598 0
a.ebiary@gmail.com
Contact person for public queries
Name 47599 0
Ahmad El-Ebiary
Address 47599 0
Kafr-Esam Street, Medical Campus of Tanta University, Faculty of Medicine (Department of Forensic Medicine and Clinical Toxicology), Tanta, Egypt
Country 47599 0
Egypt
Phone 47599 0
+2 010 61277577
Fax 47599 0
Email 47599 0
a.ebiary@gmail.com
Contact person for scientific queries
Name 47600 0
Ahmad El-Ebiary
Address 47600 0
Kafr-Esam Street, Medical Campus of Tanta University, Faculty of Medicine (Department of Forensic Medicine and Clinical Toxicology), Tanta, Egypt
Country 47600 0
Egypt
Phone 47600 0
+2 010 61277577
Fax 47600 0
Email 47600 0
a.ebiary@gmail.com

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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3969Plain language summaryNo Organophosphorus poisoning is a major global healt... [More Details]
4471Study results articleYes Basic Clin Pharmacol Toxicol. 2016 Aug;119(2):222-... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseN-acetylcysteine in Acute Organophosphorus Pesticide Poisoning: A Randomized, Clinical Trial.2016https://dx.doi.org/10.1111/bcpt.12554
N.B. These documents automatically identified may not have been verified by the study sponsor.