Comparison of Treated with 12-Hour vs. 21-Hour Acetylcysteine Infusion in patients with acute poisoning due to acetaminophen referred to Isfahan Khorshid Hospital
Comparison of Treated with 12-Hour vs. 21-Hour Acetylcysteine Infusion in patients with acute poisoning due to acetaminophen referred to Isfahan Khorshid hospital
Design
A clinical trial with 2 intervention groups, with parallel groups, three-way blind, randomized, phase 3 on 80 patients. Excel software rand function was used for randomization
Settings and conduct
This study will be performed in Poisoning Emergency ward - at Khorshid hospital Isfahan. The principal investigator and the nursing staff have no knowledge about the selection of the patient as control or intervention, and only after selecting the patient based on the Excel round function, they prepare and prescribe medication..
Participants/Inclusion and exclusion criteria
Entry requirements :
1. Consent to participate in the study
2. Acetaminophen poisoning based on the toxic serum level of acetaminophen
3. Age between 13 to 60 years
No entry conditions:
5. History of chronic liver and kidney patients
6. History of cancer and completion of chemotherapy
7. Take high-dose corticosteroids
Concomitant use of drugs other than acetaminophen in toxic doses
9. Previous ECG disrupted
Intervention groups
Prescribing different treatment regimens of N-acetylcysteine in the two intervention groups in patients with acetaminophen poisoning
Main outcome variables
Length of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111003007710N2
Registration date:2022-06-08, 1401/03/18
Registration timing:registered_while_recruiting
Last update:2022-06-08, 1401/03/18
Update count:0
Registration date
2022-06-08, 1401/03/18
Registrant information
Name
Farzad Gheshlaghi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1669 7823
Email address
gheshlaghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Treated with 12-Hour vs. 21-Hour Acetylcysteine Infusion in patients with acute poisoning due to acetaminophen referred to Isfahan Khorshid Hospital
Public title
Acetylcysteine Infusion efficacy in patients with acute Acetamonophen poisoning l
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who referred to the poisoned emergency room of Khorsid Hospital in Isfahan after poisoning with a toxic dose of acetaminophen
Exclusion criteria:
History of chronic liver and kidney disease
History of cancer and chemotherapy
Take high doses of corticosteroids
Concomitant use of drugs other than acetaminophen in toxic doses
Previous unnormal ECG
Age
From 13 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Using the rand function in Excel software, a number is generated for each patient, if the number was even in the control group and if it was an odd number in the case group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The outcome assessor is not involved in the allocation process and selection groups and drug administrator, so he/she is blind.
The statistician is unaware of the treatment performed in the two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Doesn't have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Isfahan University of Medical Sciences
Street address
Ostandari Ave. ,Khoorshid Hospital
City
Isfahan
Province
Isfehan
Postal code
8145831451
Approval date
2022-05-17, 1401/02/27
Ethics committee reference number
IR.MUI.MED.REC.1401.066
Health conditions studied
1
Description of health condition studied
Acetaminophen poisoning
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood Acetaminophen level
Timepoint
Upon arrival, two hours before the end of the protocol, 24 hours and one week after discharge
Method of measurement
HPLC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the treatment protocol with NAC is 100 mg / kg in 200 cc of 5% dextrose serum during the first hour and then 200 mg / kg in 1000 cc of 5% dextrose serum for 10 hours.
Category
Treatment - Drugs
2
Description
Control group: group receiving NAC regimen for 21 hours, initial dose 150 mg / kg for 20 minutes, then 50 mg / kg for 4 hours and then 100 mg / kg for 16 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poisoning Emergency ward - Khorshid Hospital
Full name of responsible person
Nasim Tavakoli
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2255
Fax
+98 31 3222 2255
Email
Drnasimtavakoli@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansoor Siavash
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nasim Tavakoli
Position
Clinical Toxicology fellowship
Latest degree
Specialist
Other areas of specialty/work
Toxicology
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2255
Email
Drnasimtavakoli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farzad Gheshlaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Toxicology
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2255
Email
gheshlaghi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nasim Tavakoli
Position
Clinical toxicology fellowship
Latest degree
Specialist
Other areas of specialty/work
Toxicology
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2255
Email
Drnasimtavakoli@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available