Protocol summary

Summary
This study is double blind randomized control trial in phase 4. Study population is referred patients to baharloos’ hospital toxicological emergency ward. Samples allocated by randomized block sampling method in two standard (20-hour intravenous NAC protocol is 150 mg/kg loading dose over 15 minutes, followed by an additional dose of 50 mg/kg over 4 hours, and then 100 mg/kg over 16 hours, for a total dose 300 mg/kg) and experimental group (The 72-hour oral regimen is a 140-mg/kg loading dose followed by 70 mg/kg for 17 additional doses, for a total dose of 1330 mg/kg. Inclusion criteria: Patients over 18 year’s old age which consume 7.5 gr acetaminophen during 24 hr ago will be concluding in the study. Exclusion criteria: Admission after 24 hr after consumption of acetaminophen, co ingestion of cholinergic drugs, primary unconsciousness, primary hepatic encephalopathy, presence of status epilepticus after NAC therapy, history of asthma and anaphylactoid reactions will considering as exclusion criteria. Acetaminophen serum concentration measured in the first of the study. Liver enzyme including AST, ALT and Prothrombin measured in the first of the study and for 72 hour Created complications and therapeutic effect will record and will compare by means of statistical analysis. Study duration is one-year from January 2012 to December 2012.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112218488N1
Registration date: 2013-05-10, 1392/02/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-10, 1392/02/20
Registrant information
Name
Hamed Pouraziz Khasmakhi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 5588
Email address
h-pouraziz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2012-12-30, 1391/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of oral and intravenous acetylcysteine ​​in treating acetaminophen poisoning in admitted patients to poisoning emergency ward of Baharloo Hospital (2011-2012)
Public title
Comparison of the effects of oral and intravenous acetylcysteine ​​in treating acetaminophen poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Patients over 18 years old age which admitted to toxicological emergency ward of Baharloo hospital in Tehran which consume 7.5 gr acetaminophen during 24 hr ago will be conclude in the study. Inclusion Criteria: Patients over 18 years old age; consumption 7.5 gr acetaminophen during 24 hr before admittion Exclusion Criteria: Admission after 24 hr after consumption of acetaminophen; Co ingestion of cholinergic drugs; Primary unconsciousness; Primary hepatic encephalopathy; Presence of status epilepticus after NAC therapy; History of asthma and anaphylactiod reactions
Age
From 18 years old to 99 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in Research, Tehran University of Medical Sciences
Street address
Ethics committee in Research, Vice chancellor of Research, Keshavarz Blv
City
Tehran
Postal code
Approval date
2012-02-26, 1390/12/07
Ethics committee reference number
2348/130/د/90

Health conditions studied

1

Description of health condition studied
Acetaminophen Poisoning
ICD-10 code
T39.8
ICD-10 code description
Other nonopioid analgesics and antipyretics, not elsewhere classified

Primary outcomes

1

Description
AST
Timepoint
First of the study and 72 hour after treatment
Method of measurement
Serum concentration

2

Description
ALT
Timepoint
First of the study and 72 hour after treatment
Method of measurement
Serum concentration

3

Description
Bilirubin
Timepoint
First of the study and 72 hour after treatment
Method of measurement
Serum concentration

4

Description
Prothrombin time
Timepoint
First of the study and 72 hour after treatment
Method of measurement
Serum concentration

Secondary outcomes

1

Description
Treatment complication
Timepoint
At the first of the study up to 24 hour
Method of measurement
upon history and physical examination during treatment

Intervention groups

1

Description
Standard (20-hour intravenous NAC protocol is 150 mg/kg loading dose over 15 minutes, followed by an additional dose of 50 mg/kg over 4 hours, and then 100 mg/kg over 16 hours, for a total dose 300 mg/kg)
Category
Treatment - Drugs

2

Description
Experimental group (The 72-hour oral regimen is a 140-mg/kg loading dose followed by 70 mg/kg for 17 additional doses, for a total dose of 1330 mg/kg.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Poisoning Emergency Ward, Bharloo Hospital
Full name of responsible person
Dr. Hamed Pouraziz
Street address
Behdari Sqr, Baharloo Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of School of Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
Research Deputy, School of Medicine, Poursina Str
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of School of Medicine, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Hamed Pouraziz
Position
Assistant of Forensic Medicine
Other areas of specialty/work
Street address
Forensic Medicine Department, School of Medicine, Poursina Str
City
Tehran
Postal code
Phone
+98 21 6640 5588
Fax
Email
h-pouraziz@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Hamed Pouraziz
Position
Assistant of Forensic Medicine
Other areas of specialty/work
Street address
Forensic Medicine Department, School of Medicine, Poursina Str
City
Tehran
Postal code
Phone
+98 21 6640 5588
Fax
Email
h-pouraziz@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Hamed Pouraziz
Position
Assistant of Forensic Medicine
Other areas of specialty/work
Street address
Forensic Medicine Department, School of Medicine, Poursina Str
City
Tehran
Postal code
Phone
+98 21 6640 5588
Fax
Email
h-pouraziz@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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