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Clinical trial of comparison of magnesium sulfate and placebo as supplement to standard treatment in patients with organophosphorus poisoning.

Protocol summary

Summary
Objectives: Clinical trial of comparison of magnesium sulfate and placebo as supplement to standard treatment in patients with organophosphorus poisoning. Design and setting: A randomized, double-blind, clinical trial study, single center, clinical trial phase 3, 80 Samples selected via patients with poisoning referred to the emergency of Valiasr and Amiralmomenin Hospitals of Arak in 15 months and block randomized into two groups. Inclusion criteria: Age 18 to 65 years old; Taking time less than 2 hours after poisoning. Exclusion criteria: Concomitant use of drugs or other substance accidentally or as a suicidal attempt; History of severe complications or sensitivity to Magnesium sulfate. Interventions: Intervention group receives, Magnesium sulfate 50% at a dose of 2 grams bolus infusion for 30 minutes plus routine treatment, followed by the same dose infusion every 2 hours up to 3 doses. Control group receives placebo (normal saline) as same volume of magnesium sulfate added to routine treatment. Main outcome measures: Serum level of electrolytes, blood sugar, kidney and liver function tests, arterial blood gasses, size of pupils, deep tendon reflexes, fasciculation severity, respiratory crackle, salivary secretions and in case of intubation, tracheal secretions record every 30 minutes after each injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092823552N10
Registration date: 2016-11-07, 1395/08/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-07, 1395/08/17
Registrant information
Name
Abolfazl Jokar
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 2134
Email address
dr.a.jokar@gmail.com
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2016-10-17, 1395/07/26
Expected recruitment end date
2018-01-16, 1396/10/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of magnesium sulfate and placebo as supplement to standard treatment in patients with organophosphorus poisoning.
Public title
Effect of Magnesium sulfate in organophosphorus poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 to 65 years old; patients with acute organophosphorus poisoning who do not receive medical care in another medical center; Taking time less than 2 hours after poisoning; Patients satisfaction. Exclusion criteria: Unwillingness to participate in the study; Concomitant use of drugs or other substance accidentally or as a suicidal attempt; History of severe complications or sensitivity to Magnesium sulfate; History of heart block, Myocardial infarction, severe renal failure, Hepatitis and Addison's disease; Patients death.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study the randomization was conducted with block randomization method

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University Of Medical Science, Basij Square, Arak
City
Arak
Postal code
Approval date
2016-10-17, 1395/07/26
Ethics committee reference number
IR.ARAKMU.REC.1395.260

Health conditions studied

1

Description of health condition studied
organophosphorus poisoning
ICD-10 code
T44
ICD-10 code description
Poisoning by drugs primarily affecting the autonomic nervous system

2

Description of health condition studied
organophosphorus poisoning
ICD-10 code
T60.0
ICD-10 code description
Organophosphate and carbamate insecticides

Primary outcomes

1

Description
tracheal secretions
Timepoint
every 30 minutes after each injection
Method of measurement
Physical examination

2

Description
respiratory crackle
Timepoint
every 30 minutes after each injection
Method of measurement
Physical examination

3

Description
Size of pupils
Timepoint
every 30 minutes after each injection
Method of measurement
Physical examination

4

Description
deep tendon reflexes
Timepoint
every 30 minutes after each injection
Method of measurement
Physical examination

5

Description
salivary secretions
Timepoint
every 30 minutes after each injection
Method of measurement
Physical examination

6

Description
fasciculation severity
Timepoint
every 30 minutes after each injection
Method of measurement
Physical examination

Secondary outcomes

1

Description
Liver function test
Timepoint
every 30 minutes after each injection
Method of measurement
Blood test

2

Description
Blood urea nitrogen
Timepoint
every 30 minutes after each injection
Method of measurement
Blood test

3

Description
creatinine
Timepoint
every 30 minutes after each injection
Method of measurement
Blood test

4

Description
Serum level of electrolytes
Timepoint
every 30 minutes after each injection
Method of measurement
Blood test

5

Description
Blood sugar
Timepoint
every 30 minutes after each injection
Method of measurement
Blood test

6

Description
Arterial blood gasses
Timepoint
every 30 minutes after each injection
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group receive, Magnesium sulfate 50% at a dose of 2 grams bolus infusion for 30 minutes plus routine treatment, followed by the same dose infusion every 2 hours up to 3 doses.
Category
Treatment - Drugs

2

Description
Control group receive placebo (normal saline) as same volume of magnesium sulfate added to routine treatment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Abolfazl Jokar
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak, Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr. Mohammad Rafiee
Street address
Arak University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice Chancellor for Research
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
Vali-e-Asr hospital
Full name of responsible person
Dr Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak, Markazi, Iran
City
Arak
Postal code
Phone
+98 86 3223 1104
Fax
Email
dr.a.jokar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vali-e-Asr hospital
Full name of responsible person
Dr Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3223 1104
Fax
Email
dr.a.jokar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vali-e-Asr hospital
Full name of responsible person
Dr Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak, Iran
City
Arak
Postal code
Phone
00
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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