Protocol summary

Summary
Comparing therapeutic effects of sodium bicarbonate, magnesium sulfate, both and none of them in moderate and severe acute organophosphorous pesticide poisoning. Objectives: This trial is held in developing a more effective treatment regimen for acute organophosphorous poisoning. Design: This is a double-blind, parallel-group study on a total target sample size of 120 patients aged 14 to 65 years old with moderate and severe acute organophosphorous pesticide poisoning . Setting and conduct: Based on the two last digits of their dossiers' number, all eligible participants will be assigned into 4 parallel groups in 1:1:1:1 ratio to receive either one of the 3 supplementary regimens in three intervention groups or merely the conventional treatment in a no supplementary treatment control group. Major inclusion criteria: All patients aged 14 to 65 years old with moderate to severe acute organophosphorous pesticide poisoning referring to Imam Reza Hospital, Mashhad, Iran, will enter the study followed by obtaining an informed consent. Major exclusion criteria: Evidence of heart and kidney dysfunction and magnesium intoxication will be considered as exclusion criteria. Intervention: All patients will receive the conventional treatment; besides, they will receive intravenous infusion of sodium bicarbonate 7.5% for the first 3 days of hospitalization, aiming at arterial pH between 7.45 and 7.55 (first study group), intravenous infusion of magnesium sulfate 20% in the very beginning of admission (second study group), intravenous infusion of both above-mentioned supplementary treatments (third study group). Main outcome measures: Ultimately, based on their dossier's notes, the principle researcher will inspect variables including the dosage of Atropine administered for patients' Atropinization, hospitalization duration, the necessity to Intensive Care Unit, the necessity to mechanical ventilation, the necessity to Benzodiazepines, seizure incidence and their final clinical outcome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803031187N2
Registration date: 2014-12-17, 1393/09/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-17, 1393/09/26
Registrant information
Name
Reza Afshari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 8973
Email address
afsharir@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2008-06-21, 1387/04/01
Expected recruitment end date
2009-09-21, 1388/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing therapeutic effects of sodium bicarbonate with magnesium sulfate in moderate and severe acute organophosphorous pesticide poisoning.
Public title
Studying administration of sodium bicarbonate and magnesium sulfate in clinical betterment of acute organophosphorous pesticide poisoning.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients aged 14 to 65 years old with moderate and severe acute organophosphorous pesticide poisoning referring to Imam Reza Hospital, Mashhad, Iran who or whose guardian has confirmed the relevant informed consent. Exclusion criteria: Any evidence of conductive heart diseases and myocardial injuries (inspected by Electrocardiography and plasma Troponin, every 12 hours respectively); renal dysfunction (less than 100 ML urine output for every 4 hours); concurrent administration of Digitals or Central Nervous System suppressors or Neuromuscular Junction blockers (through patients' drug history); any manifestation of magnesium intoxication (through physical examination every 2 hours while administrating magnesium sulfate).
Age
From 14 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All patients who meet our including criteria, regardless of whether they will be put into the control or study groups, will be asked to confirm the informed consent. Besides, the principle researcher who is responsible for investigating the study's variables is totally different from the therapists who allocate the patients into the four groups, based on the two last digit of their dossiers' number (randomized numbers chart) , resulting in the project being double blind.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University Ethics Committee, Mashhad University of Medical Sciences (MUMS)
Street address
Mashhad University of Medical Sciences central office, Daneshgah St.
City
Mashhad
Postal code
91375-345
Approval date
2007-02-13, 1385/11/24
Ethics committee reference number
84386

Health conditions studied

1

Description of health condition studied
Moderate and severe acute Organophosphorous pesticide poisoning
ICD-10 code
T60.0
ICD-10 code description
Organophosphorous and Carbamate insecticides

Primary outcomes

1

Description
The dosage of Atropine administered for patients' Atropinization
Timepoint
In the first day of admission
Method of measurement
In scale of milligrams and according to the notes of patients' dossiers

2

Description
Hospitalization duration
Timepoint
At the end of hospitalization
Method of measurement
In scale of days and according to the notes of patients' dossiers

3

Description
Necessity to the Intensive Care Unit
Timepoint
Every morning and at the end of hospitalization
Method of measurement
According to the notes of patients' dossiers

4

Description
Necessity to mechanical ventilation
Timepoint
Every morning and at the end of hospitalization
Method of measurement
According to the notes of patients' dossiers

5

Description
Necessity to administrating Benzodiazepines
Timepoint
Every 12 hours and at the end of hospitalization
Method of measurement
According to the notes of patients' dossiers

6

Description
Seizure incidence
Timepoint
Every day and at the end of hospitalization
Method of measurement
According to the notes of patients' dossiers

7

Description
Patients' outcome
Timepoint
At the end of hospitalization
Method of measurement
According to the notes of patients' dossiers, based on whether discharged with no organophosphorous poisoning complications, discharged with some organophosphorous poisoning complications and death

Secondary outcomes

1

Description
Arterial blood pH
Timepoint
Every 12 hours
Method of measurement
Arterial blood pH measurement by pH meter

Intervention groups

1

Description
ّFirst intervention group: Intravenous infusion of 6 to 12 Sodium Bicarbonate (Pasteur Institute) 7.5% 50 ML Bags in every 24 hours for the first 3 days of hospitalization, aiming at arterial pH between 7.45 and 7.55.
Category
Treatment - Drugs

2

Description
Second intervention group: Intravenous infusion of Magnesium Sulfate (Samen Corporation) 20% 10 ML Vial, 4 grams in 4 hours, in the very beginning of admission.
Category
Treatment - Drugs

3

Description
Third intervention group: Intravenous infusion of 6 to 12 Sodium Bicarbonate (Pasteur Institute) 7.5% 50 ML Bags in every 24 hours for the first 3 days of hospitalization, aiming at arterial pH between 7.45 and 7.55 and intravenous infusion of Magnesium Sulfate (Samen Corporation) 20% 10 ML Vial, 4 grams in 4 hours, in the very beginning of admission.
Category
Treatment - Drugs

4

Description
Control (forth) group: Merely the conventional treatment. No supplementary treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Toxicology ward, Medical Toxicology Centre and Addiction Research Center, Imam Reza Hospital
Full name of responsible person
Seyedmahyar Mohammadi
Street address
Imam Reza SQ., Ebn-e Sina St.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences (MUMS)
Full name of responsible person
Mahyar Mirheydari, MD
Street address
Mashhad University of Medical Sciences central office, Daneshgah St.
City
Mashhad
Grant name
طرح تحقیقاتی دانشگاه
Grant code / Reference number
84386
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences (MUMS)
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
Medical Toxicology Center and Addiction Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Reza afshari, M.D.
Position
Clinical toxicologist
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Sq., Ebn-E-Sina St.
City
Mashhad
Postal code
9137913316
Phone
+98 51 3859 8973
Fax
+98 51 3852 5315
Email
afsharir@mums.ac.ir
Web page address
http://www.mums.ac.ir/mtrc

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical Toxicology Center and Addiction Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Seyedmahyar Mohammadi
Position
General Practice intern
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Sq., Ibn-E-Sina St.
City
Mashhad
Postal code
9137913316
Phone
+98 51 3859 8973
Fax
+98 51 3852 5315
Email
mahyar.mohamadii@gmail.com
Web page address
http://www.mums.ac.ir/mtrc

Person responsible for updating data

Contact
Name of organization / entity
Medical Toxicology Center and Addiction Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Seyedmahyar Mohammadi
Position
General Practice Intern
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Sq., Ebn-E-Sina St.
City
Mashhad
Postal code
9137913316
Phone
+98 51 3859 8973
Fax
+98 51 3852 5315
Email
mahyar.mohamadii@gmail.com
Web page address
http://www.mums.ac.ir/mtrc

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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