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Determination of therapeutic efficacy of N-acetyl cysteine with the combination of N-acetyl cysteine and Cimetidine in acute acetaminophen toxicity

Protocol summary

Summary
1) Objectives: Determination of the therapeutic efficacy of a combination of N-acetyl-cysteine (NAC) and cimetidine, in comparison with N-acetyl-cysteine alone, in acute acetaminophen toxicity. 2) Design: the present study is not belinded, randomized controlled trial. 3) The inclusion major criteria are: having para-clinical acetaminophen toxicity (toxic acetaminophen serum levels), and referring to the emergency poisoning department of Imam Reza Hospital, less than 8 hours from the poisoning. Exclusion major criteria are as follows: having multiple toxicities; simultaneous diseases affecting the liver enzymes (e.g. heart failure, congenital liver defects, and hepatitis); recent (less than a week) or regular consumption of other drugs;Those patients who didn’t consent to the treatment, or were discharged from the hospital, were also excluded from the study. 4) Setting and conduct: among the patients admitted to the emergency department of Imam Reza Hospital, in the third quarter of 1392, those with suspected acetaminophen toxicity (according to the statements made by the patients, and their acquaintances, or the found evidence)were admitted to the hospital; if the clinical toxicity was approved, the patients were treated (based on the risk assessment nomogram of acetaminophen serum level), either with NAC or a combination of cimetidine injection + NAC . 5) interventions: N-acetyl-cysteine , a combination of N-acetyl-cysteine and cimetidine 6) main outcome: Serum acetaminophen levels, serum levels of aminotransferase

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102915204N1
Registration date: 2014-01-01, 1392/10/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-01, 1392/10/11
Registrant information
Name
Farhad Bagherian
Name of organization / entity
Imam Reza Hospital, Emergency Department
Country
Iran (Islamic Republic of)
Phone
+98 51 1841 8890
Email address
bagherianf901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mashhad University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of therapeutic efficacy of N-acetyl cysteine with the combination of N-acetyl cysteine and Cimetidine in acute acetaminophen toxicity
Public title
Comparing therapeutic efficacy of N-acetyl cysteine with the combination of N-acetyl cysteine and Cimetidine in acute acetaminophen toxicity
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion major criteria to study, are: having para-clinical acetaminophen toxicity (toxic acetaminophen serum levels), and referring to the emergency poisoning department of Imam Reza Hospital, less than 8 hours from the poisoning. Exclusion major criteria from study, are as follows: having multiple toxicities; simultaneous diseases affecting the liver enzymes (e.g. heart failure, congenital liver defects, and hepatitis); recent (less than a week) or regular consumption of other drugs;Those patients who didn’t consent to the treatment, or were discharged from the hospital, were also excluded from the study.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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, Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah Street, Ghoreishi Building, Mshhad
City
Mashhad
Postal code
Approval date
2013-07-03, 1392/04/12
Ethics committee reference number
920427/1/69

Health conditions studied

1

Description of health condition studied
Acute acetaminophen toxicity
ICD-10 code
T36, T37,
ICD-10 code description
Poisoning by drugs, medicaments and biological substances

Primary outcomes

1

Description
Serum level of acetaminophen
Timepoint
admission-next morning- discharging
Method of measurement
blood Sampling

Secondary outcomes

1

Description
Serum level of Serum aminotransferases
Timepoint
admission-next morning- discharging
Method of measurement
blood Sampling

Intervention groups

1

Description
Control group: N-acetyl cysteine patients are treated (based on the risk assessment nomogram of acetaminophen serum level)
Category
Treatment - Drugs

2

Description
Intervention group: the combination of N-acetyl cysteine and Cimetidine patients are treated (based on the risk assessment nomogram of acetaminophen serum level). Cimetidine dose: 300 milligram every 6 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency Department of Imam Reza Hospital
Full name of responsible person
Farhad Bagherian
Street address
Imam Reza Square, Ebnesina Street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ramezani
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah Street, Ghoreishi Building, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farhad Bagherian
Position
Resident
Other areas of specialty/work
Street address
Imam Reza Square, Ebnesina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1841 8890
Fax
Email
dr_f_bagherian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ebrahimi
Position
Subspecialist
Other areas of specialty/work
Street address
Imam Reza Square, Ebnesina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 511852532
Fax
Email
ebrahimimn@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farhad Bagherian
Position
Resident
Other areas of specialty/work
Street address
Imam Reza Square, Ebnesina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1841 8890
Fax
Email
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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