Tricyclic antidepressants (TCA) toxicity is one of the major causes of drug toxicity all over the world, which can cause severe cardiac and neurological effects and even mortality. Some experimental animal studies have shown that intravenous lipid emulsions can be helpful in treatment of TCA toxicity, and some case reports also confirmed these results. We are trying to find out whether intralipid do have a place in treatment of TCA toxicity. For this purpose, 108 patients with severe TCA toxicity who are visiting The Loghman Hospital (a referral toxicology center) will be randomly divided to intervention and control group. The control group would receive the standard treatment with bicarbonate and the intervention would receive standard treatment plus intravenous lipid emulsion. The outcomes that will be compared between these two groups are the time that EKG and blood pressure become normal and final mortality and morbidity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012061610017N2
Registration date:2012-07-24, 1391/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-24, 1391/05/03
Registrant information
Name
Hamed Basir Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
h-basirghafouri@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-04-25, 1391/02/06
Expected recruitment end date
2012-08-25, 1391/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of bicarbonate and bicarbonate plus intravenous lipid emulsion in tricyclic antidepressants toxicity
Public title
Therapeutic effects of intravenous lipid emulsion in tricyclic antidepressants toxicity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with TCA toxicity according to patient history by himself or other sources of history, who are over 16 and have the indication for starting bicarbonate therapy. Exclusion criteria: patients with renal failure; pulmonary edema; brain edema; toxication with carbamazepine or phenothiazine in addition to TCA.
Age
From 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
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
Research ethics committee of Tehran University of medical sciences
Street address
Headquarter for Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-04-20, 1391/02/01
Ethics committee reference number
130/2830/د/90
Health conditions studied
1
Description of health condition studied
Tricyclic antidepressants toxicity
ICD-10 code
T43.0
ICD-10 code description
Poisoning by psychotropic drugs, not elsewhere classified/Tricyclic and tetracyclic antidepressants
Primary outcomes
1
Description
Normalization time for blood pressure
Timepoint
Minutes of 30, 60, 90, 240, 480 and 720
Method of measurement
Patients’ blood pressure would be detected by mercury barometer in mmHg and the time that blood pressure reach above 90 mmHg will be noted.
2
Description
Normalization time for EKG
Timepoint
Minutes of 30, 60, 90, 240, 480 and 720
Method of measurement
Checklists to be filled by the patients physician
Secondary outcomes
1
Description
Fnal mortality and morbidity
Timepoint
At the patient discharge time
Method of measurement
Observation
Intervention groups
1
Description
Control: standard treatment of TCA toxicity which contains GI decontamination, fluid resuscitation, and intravenous bicarbonate.
Category
Treatment - Drugs
2
Description
Intervention: standard treatment of TCA toxicity which contains GI decontamination, fluid resuscitation, and intravenous bicarbonate plus 100 cc intravenous lipid emulsion 20% in 1 min and 400 cc in 20 min.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhundzadeh
Street address
First floor (No.303), School of medicine, Tehran University of Medical Siences, Pur sina street, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
School of medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr. Movahedi Behnam
Position
Emergency Medicine resident
Other areas of specialty/work
Street address
Emergency Department, Rasoul-Akram Hospital, Niayesh sreet, Satarkhan street
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
behnam2980@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine, Tehran University Of Medical Science
Full name of responsible person
Hamed Basir Ghafouri
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Emergency Department, Rasoul-Akram Hospital, Niayesh sreet, Satarkhan street
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
h-basirghafouri@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Basir Ghafouri Hamed
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Emergency Department, Rasoul-Akram Hospital, Niayesh sreet, Satarkhan street
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
h-basirghafouri@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)