In this study, our goal is to investigate the potential of triiodothyronine (T3) in protecting and improving cardiac function in people with aluminum phosphide poisoning based on the electrocardiogram and laboratory results.
Design
This study is a randomized controlled clinical trial on acute AlP-poisoned patients
Settings and conduct
Toxicology Research Center of Mashhad University of Medical Sciences, Blood samples are taken at hospital and clinical information is recorded from the file. all diagnostic tests on samples are performed in the laboratory of the Research Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. A patient who has been taking rice pills for the past 3 hours.
2. sign the informed consent form.
exclusion criteria:
1. The patient's silver nitrate test is negative.
2. The patient has taken non-phosphoric aluminum rice tablets (herbal type).
Intervention groups
Patients are examined and routinely treated for AlP poisoning, and the T3 will be given in the prescribed dose to trial group, while this will not done in the control group.
Main outcome variables
Examination of clinical signs and patients outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130811014330N8
Registration date:2021-02-11, 1399/11/23
Registration timing:retrospective
Last update:2021-02-11, 1399/11/23
Update count:0
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
Hamid Reza Rahimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2288
Email address
rahimihr891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-21, 1396/12/02
Expected recruitment end date
2020-06-17, 1399/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To determine the cardiovascular effects triodithyronine (T3) in patients poisoned with aluminum phosphide (AlP)
Public title
triodithyronine (T3) in aluminum phosphide (AlP) poisoning
The patient's silver nitrate test is negative.
The patient has taken non-phosphoric rice tablets (herbal type).
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block
Build random sequences: Randomaize.com randomization site
Allocation Concealment: SNOSE (sequentially numbered, opaque, sealed envelopes)
According to the two intervention and control groups, each block will be four. Then write a list of blocks and assign numbers to them, which will be 6 blocks according to the sample size of 24 people. Then random numbers between one and 6 are selected according to the Randomaize.com randomization site. Finally, the allocation list is written based on random numbers on the envelopes containing each block.
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
Ethic's committee of Mashhad University of Medical Sciences
Street address
Quraish bilding of MUMS, daneshghah St, Mashhad, Iran Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2017-07-05, 1396/04/14
Ethics committee reference number
IR.MUMS.fm.REC.1396.165
Health conditions studied
1
Description of health condition studied
Aluminum phosphide poisoning
ICD-10 code
T60
ICD-10 code description
Toxic effect of pesticides
Primary outcomes
1
Description
Mortality rate
Timepoint
Since the entry of the patient in the study until death or discharge from the hospital
Method of measurement
Observation & Investigation
2
Description
Cardiovascular & hemodynamic effects
Timepoint
admission time and each 24 hours
Method of measurement
Observation & Investigation
Secondary outcomes
1
Description
Malondealdehyde
Timepoint
Beginning of the study (baseline), 12 to 24 hours after inclusion
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Drug intervention with standard therapy. Drug intervention: Liothyronine tablet 50 mcg (a single dose) by nasogastric tube, after gastric lavage. Standard therapy: oxygen 100%; normal saline serum IV, 10-20 ml/kg; gastric lavage with sodium bicarbonate solution; dopamine IV, 5-15 mcg/kg/min; hydrocortisone IV, 100 mg qid; pantoprazole IV, 40 mg bid; magnesium sulfate IV infusion, 1gr qid; metoclopramide IV, 10 mg qid; calcium gluconate 10% qid.
Category
Treatment - Drugs
2
Description
Control group: Just standard therapy. Standard therapy: oxygen 100%; normal saline serum IV, 10-20 ml/kg; gastric lavage with sodium bicarbonate solution; dopamine IV, 5-15 mcg/kg/min; hydrocortisone IV, 100 mg qid; pantoprazole IV, 40 mg bid; magnesium sulfate IV infusion, 1gr qid; metoclopramide IV, 10 mg qid; calcium gluconate 10% qid.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Hamid Reza Rahimi
Street address
Imam Reza hospital Sq, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
mousavir@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences,vice chancellor for research
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Quraish bilding of MUMS, daneshghah St, Mashhad, Iran Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3800 2301
Email
rahimihr891@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences,vice chancellor for research
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 1800 2288
Fax
+98 51 1800 2287
Email
rahimihr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 1800 2288
Fax
+98 51 1800 2287
Email
rahimihr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 1800 2288
Fax
+98 51 1800 2287
Email
rahimihr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical documentation is published with confidentiality
When the data will become available and for how long
One year after the end of sampling
To whom data/document is available
Researchers in the field of toxicology
Under which criteria data/document could be used
For further research
From where data/document is obtainable
Dr. Hamid Reza Rahimi, Dr. Seyed Reza Mousavi
What processes are involved for a request to access data/document
Approved by the Research Committee of the University Toxicology Research Center