Cases will be selected among moderate to severe organophosphate poisoned patients who are recruited to Medical Toxicology Ward of Imam Reza Hospital, Mashhad, Iran and will be divided in to two groups: study and Control group. Standard organophosphate poisoning treatment (atropine and oxime) will begin for both groups. More intensive supportive cares will be done in accordance with the physician’s discretion. Blood samples will be given for Acetyl cholinesterase and butyryl cholinesterase assays, as well as hematologic and biochemical assays. In the case group, MgSO4.7H2O 20% will be administered in divided doses of 4 grms within intervals of 4 hours with the maximum of 16 grm in the first day. Equivalent patient in control group will receive the same number and volume of normal saline infusion as placebo. Mg level will be measured before the first infusion and will be continued daily. 24 hour urine collection will be done in order to Mg measurement. All the vital signs, physical examination and laboratory data and received doses of all the drugs will be recorded in predesigned forms. At last, the result of treatment will be recorded as total healing, healing with complications or death. Patients who reach normal cholinesterase levels and are also cholinergic symptoms free, will be known as complete healed patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104272083N3
Registration date:2014-08-04, 1393/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Seyed Reza Mousavi
Name of organization / entity
Imam Reza Hospital, Mashhad University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 8973
Email address
mousavir@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences, Mashhad, Iran
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effects of Magnesium Sulfate (MgSO4) in acute organophosphate pesticide poisoning
Public title
Therapeutic effects of Magnesium Sulfate (MgSO4) in acute organophosphate pesticide poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Determined acute moderate to severe organophosphate poisoning ; filling the written informed consent by the patients or close relatives in cases with diminished consciousness.
Exclusion criteria: disinclination to continue ; age of below 10 years or above 60 years old; mild organophosphate poisoning ; history of severe diseases such as heart, lung,renal or hepatic insufficiency, and metabolic diseases ; simultaneous poisoning with other chemicals ; history of epilepsy prior to the poisoning ; passing more than 24 hours after the consumption ; occurring of primary signs and symptoms of Mg poisoning in case group ; ECG changes that require different dose of MgSO4 administration or any other interfering drug
Age
From 10 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research department, Mashhad University of Medical Sciences, Mashhad, Iran
Street address
2nd floor, central building of Mashhad University of Medical Sciences (Ghorshi building), Daneshgah avenue, Mashhad, Iran
City
Mashhad
Postal code
Approval date
2014-01-11, 1392/10/21
Ethics committee reference number
921143
Health conditions studied
1
Description of health condition studied
Acute organophosphate pesticide posoning
ICD-10 code
T60.0
ICD-10 code description
Organophosphate and carbamate insecticides
Primary outcomes
1
Description
RBC Cholinesterase level
Timepoint
prior to the treatment and daily
Method of measurement
blood sample
2
Description
ICU admission
Timepoint
after the intervention
Method of measurement
Number of days during ICU admission
3
Description
mechanical ventilation
Timepoint
after the intervention
Method of measurement
number of days within the patient needs mechanical ventilation
4
Description
patients' mortality
Timepoint
after the intervention
Method of measurement
observation
5
Description
post-loading maintenance doses of atropine
Timepoint
at the beginning and at the end of patient's admission
Method of measurement
sum of maintenance of atropine in each day of admission (mg)
Secondary outcomes
1
Description
hypotension as a complication of MgSO4 infusion
Timepoint
continuously from the beginning of the infusion
Method of measurement
cardiac monitoring
2
Description
diminished respiratory rate as a complication of MgSO4 infusion
Timepoint
continuously from the beginning of the infusion
Method of measurement
cardiac monitoring
3
Description
diminished deep tendon reflexes as a complication of MgSO4 infusion
Timepoint
each 5 minutes from the beginning of the infusion
Method of measurement
physical examination
Intervention groups
1
Description
MgSO4.7H2O 20% will administer in divided doses of 4 grms with interval of 4 hours with the maximum of 16 grm. MgSO4 will be administered as infusion with 250 cc of normal saline within 20 minutes
Category
Treatment - Drugs
2
Description
290 cc normal saline will be infused within 20 minutes in control group, in accordance with number and time interval of infusions in intervention group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Medical Toxicology Research Center (MTRC)
Full name of responsible person
Dr. Seyed Reza Mousavi
Street address
Mashhad, Imam Reza Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research- Mashhad University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Dr. Tafaghodi
Street address
Research Department (Ghoreyshi building) - 2nd floor - Daneshgah Avenue
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, Mashhad, Iran
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 Research Center (MTRC)
Full name of responsible person
Seyed Reza Mousavi
Position
Assistant professor of Medical Toxicology
Other areas of specialty/work
Street address
Imam Reza Hospital, Medical Toxicology Research Center (MTRC)
City
Mashhad
Postal code
Phone
+98 51 1859 8973
Fax
+98 80 02467
Email
mousavir@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Meical Toxicology Research Center (MTRC)
Full name of responsible person
Dr. Mahdi Balali-Mood
Position
MD - PhD. in Clinical Pharmacology and Toxicology
Other areas of specialty/work
Street address
Imam Reza Hospital, Meical Toxicology Research Center (MTRC)
City
Mashhad
Postal code
Phone
+98 51 1859 8973
Fax
+98 80 02467
Email
balalimoodm@mums.ac.ir mbalalimood@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Toxicology Research Center (MTRC)
Full name of responsible person
Seyed Reza Mosavi
Position
Assistant professor of clinical toxicology
Other areas of specialty/work
Street address
Imam Reza Hospital, Medical Toxicology Research Center (MTRC)
City
Mashhad
Postal code
Phone
+98 51 1859 8973
Fax
+98 80 02467
Email
mousavir@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)