The aim of this study is to compare continuous infusion versus intermittent bolus injection of pralidoxime for the treatment of organophosphate poisoning
Design
Two arm parallel groups randomized trial with single blinding
Settings and conduct
Emergency Department of Ali-Asghar Hospital. The patients will be blinded from study interventions
Participants/Inclusion and exclusion criteria
Patients aged between 18 to 60 years with organophosphate poisoning admitted to the emergency department of Ali-Asghar Hospital. Exclusion criteria include patients who are poisoned with carbamate compounds, patients who have received treatment prior to arriving at our center, and patients with history of other pre-existing comorbid conditions and history of lung disease
Intervention groups
The patients will be randomized into two study groups. At first, all patients will be received IV bolus 1-2g/20min Pralidoxime as loading dose, then will be repeated every 6 hours for the patients in the group I, while the patients in the group II will be administered 8g/24 hours Pralidoxime by continuous infusion.
Main outcome variables
The primary outcomes are duration of atropine therapy, and duration of ICU stay. In addition, we will be considered mortality rate as secondary outcome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180613040087N1
Registration date:2018-08-01, 1397/05/10
Registration timing:registered_while_recruiting
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Azadeh Tafakori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3822 9856
Email address
tafakori@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of continuous infusion versus intermittent bolus injection of Pralidoxime for the treatment of Organophosphate poisoning
Public title
Treatment of Organophosphate poisoning with Pralidoxime
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Organophosphate poisoning admitted to the emergency department of Ali-Asghar Hospital
Exclusion criteria:
Patients with age less than 18 or more than 80 years old
Patients who are poisoned with Carbamate compounds
Patients who have received treatment prior to arriving at our center
Patients with history of history of lung diseases
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by using a randomization table based on the registration number of the patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
Just patients will be blinded to the intervention allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
1456946111
Approval date
2018-06-18, 1397/03/28
Ethics committee reference number
IR.SUMS.MED.REC.1397.147
Health conditions studied
1
Description of health condition studied
Organophosphate poisoning
ICD-10 code
T60.0
ICD-10 code description
Toxic effect of organophosphate and carbamate insecticides
Primary outcomes
1
Description
Duration of Atropine therapy
Timepoint
From admission to hospital discharge
Method of measurement
Based on day
2
Description
Duration of ICU stay
Timepoint
From admission to hospital discharge
Method of measurement
Based on day
Secondary outcomes
1
Description
Mortality rate
Timepoint
From admission to hospital discharge
Method of measurement
Census
Intervention groups
1
Description
Intervention group: Continuous infusion of 8g pralidoxime in 24 hours
Category
Treatment - Drugs
2
Description
Intervention group: Bolus injection of 1-2g pralidoxime in 20 minutes, then will be repeated every 6 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Asghar Hospital
Full name of responsible person
Azadeh Tafakori
Street address
Emergency Department of Ali-Asghar Hospital, Meshkin Faam Street
City
Shiraz
Province
Fars
Postal code
71879-15998
Phone
+98 71 3229 0156
Email
aliasghar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Hasani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Department of Emergency Medicine, Nemazee Hospital, Zand Ave
City
Shiraz
Province
Fars
Postal code
71348-45794
Phone
+98 71 3647 4332
Email
hasaniz@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Tafakori
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of Emergency Medicine, Nemazee Hospital, Zand Ave
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4332
Email
dr.azadeh.tafakori@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Tafakori
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of Emergency Medicine, Nemazee Hospital, Zand Ave
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4332
Email
dr.azadeh.tafakori@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data related to the patients will be shared after identifying the patients.
When the data will become available and for how long
Starting 1 month after publication
To whom data/document is available
This only available for people working in academic institutions
Under which criteria data/document could be used
All statistical analysis are allowed in line with the objectives of the study. Application terms for access to data including: People working in academic institutions who have registered a protocol liked our study. People are committed to data protection.