The purpose of this study was to investigate the therapeutic effects of magnesium sulfate in patients with tricyclic antideprsants. The study population was the patients referred to emergency ward of Loghman Hakim Poison hospital with history of TCA poisoning. A total of 72 patients were randomized into. The patients in the control group received sodium bicarbonate but in the intervention group received Sodium Bicarbonate as well as Magnesium Sulfate %20, 1 gram IV every 6 hours. Mortality rate and hospital stay was measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811142717N1
Registration date:2010-05-29, 1389/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Babak Mostafazadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5540 9534
Email address
mstzbmd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shaheed Beheshti University of Medical sciences
Expected recruitment start date
2009-03-01, 1387/12/11
Expected recruitment end date
2010-02-20, 1388/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of magnesium sulfate in patients with tricyclic anti depresant to reduce mortality rates
Public title
Effects of magnesium sulfate in patients poisoned with tricyclic antidepressants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: TCA poisoning with more than 20mg/kg TCA, Widening QRS> 12msec, PH<7.2, and/or presence of convulsion
Exclusion criteria: The other causes of seizures, including trauma, tramadol poisoning, Hypoglycemia, ECG findings due to ischemic heart disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Beheshti university of Medical sciences
Street address
Shaheed Beheshty university of Medical sciences, Tehran
City
Tehran
Postal code
Approval date
2009-02-02, 1387/11/14
Ethics committee reference number
87-01-113-5738
Health conditions studied
1
Description of health condition studied
TCA poisoning
ICD-10 code
T43.0
ICD-10 code description
Tricyclic and tetracyclic antidepressants
Primary outcomes
1
Description
Mortality rate
Timepoint
6 h and 24h after admission and discharge time
Method of measurement
mortality rate
2
Description
Admission days
Timepoint
discharge time
Method of measurement
Hospital Recording
Secondary outcomes
1
Description
Morbidity rate
Timepoint
every week
Method of measurement
Clinical assesment
2
Description
Complications of admission
Timepoint
every week
Method of measurement
Clinical assesment
Intervention groups
1
Description
Sodium bicarbonate, 88 milliequivalent, IV, single dose at the begining of treatment
Category
Treatment - Drugs
2
Description
Sodium bicarbonate with 88 milliequivalent IV, single dose at the begining of treatment as well as Magnesium Sulfate 20%, 1 gram IV, every 6 hours for 4 doses
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Babak Mostafazadeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Babak Mostafazadeh
Street address
Shahid Beheshti University of Medical Sciences, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Mediacal Sciences
Full name of responsible person
Dr. Babak Mostafazadeh
Position
Assistant Professor, Medical Toxicology and Forensic Medicine
Other areas of specialty/work
Street address
Loghman Hakim Hospital, Karegar Avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 5540 9534
Fax
+98 21 5540 9534
Email
mstzbmd@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Babak Mostafazadeh
Position
MD, Assistant Professor, Medical Toxicology and Forensic Medicine
Other areas of specialty/work
Street address
Loghman Hakim Hospital, Karegar Avenue
City
Tehran
Postal code
Phone
+98 21 5540 9534
Fax
+98 21 5540 9534
Email
mstzbmd@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Mediacal Sciences
Full name of responsible person
Babak Mostafazadeh
Position
MD, Assistant Professor, Medical Toxicology and Forensic Medicine
Other areas of specialty/work
Street address
Loghman Hakim Hospital, Karegar Avenue
City
Tehran
Postal code
Phone
+98 21 5540 9534
Fax
+98 21 5540 9534
Email
mstzbmd@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)