Determining the effectiveness of Dihydroxyacetone (DHA) serum in the treatment of patients with aluminum phosphide (rice tablet) poisoning by assessing the blood pressure and ECG changes and cardiac function
Determining the effectiveness of dihydroxyacetone (DHA) serum in the treatment of aluminum phosphide (rice tablet) poisoning by assessing blood pressure and ECG changes and cardiac function
Design
A pre-post, phase 2 on 10 patients, uncontrolled, prospective, single-centre clinical trial.
Settings and conduct
In this study, DHA serum is intravenously infused into patients who have been poisoned with rice tablets and are admitted to Imam Hassan Hospital (North Khorasan University of Medical Sciences, Bojnurd, Iran). The study outcomes are evaluated in terms of the effectiveness of DHA before and after the infusion and until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: People who have been poisoned with aluminum phosphide (rice tablets). Exclusion Criteria: 1- Conditions where the amount of aluminum phosphide used in rice tablets cannot be trusted; e.g., expired rice tablets, being exposed to moisture or dissolved in water before use, crushed before use, vomiting after taking the tablet. 2- Banan tablets (the same as garlic tablets) have been taken.
Intervention groups
Intravenous infusion of ready-to-inject dihydroxyacetone (DHA) serum in people poisoned with aluminum phosphide
Main outcome variables
Changes in blood pressure, changes in electrocardiogram (ECG), contractile strength of the heart by measuring EF
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150606022569N4
Registration date:2023-10-26, 1402/08/04
Registration timing:prospective
Last update:2023-10-26, 1402/08/04
Update count:0
Registration date
2023-10-26, 1402/08/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3223 9001
Email address
hosseini1115@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-05, 1402/08/14
Expected recruitment end date
2025-11-05, 1404/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of Dihydroxyacetone (DHA) serum in the treatment of patients with aluminum phosphide (rice tablet) poisoning by assessing the blood pressure and ECG changes and cardiac function
Public title
The effectiveness of DHA serum in the treatment of aluminum phosphide poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
This study is conducted on people who have been poisoned (intentionally or unintentionally) with aluminum phosphide (rice tablets).
Exclusion criteria:
The rice tablet(s) is/are exceeded their expiration date.
The tablet(s) is/are exposed to moisture and release(s) its/their phosphine gas.
The tablet(s) is/are dissolved in water prior to use and so release(s) its/their phosphine gas.
The tablet(s) is/are thoroughly crushed before use, resulting in a large amount of phosphine gas being released.
The tablet(s) and its/their contents are thrown out immediately after eating due to vomiting.
The person ingested the "Banan tablet" (a tablet that contains garlic, salt and starch, and is sometimes erroneously referred to as the rice tablet in Iran).
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
A Prospective Pre-Post Study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
North Khorasan University of Medical Sciences
Street address
Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Approval date
2022-05-22, 1401/03/01
Ethics committee reference number
IR.NKUMS.REC.1401.005
Health conditions studied
1
Description of health condition studied
Poisoning with rice tablets (aluminum phosphide)
ICD-10 code
T60.4
ICD-10 code description
Toxic effect of rodenticides
Primary outcomes
1
Description
Changes in blood pressure
Timepoint
At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge.
Method of measurement
Blood pressure monitor
2
Description
Electrocardiogram (ECG) changes
Timepoint
At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge.
Method of measurement
Electrocardiography
3
Description
Contractile strength of the heart by measuring EF
Timepoint
At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge.
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Arterial oxygen saturation
Timepoint
At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge
Method of measurement
Measurement of arterial oxygen saturation
2
Description
Blood glucose
Timepoint
At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge
Method of measurement
Laboratory measurement of blood glucose
3
Description
Level of consciousness
Timepoint
At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge
Method of measurement
Using the Glasgow Coma Scale (GCS)
4
Description
Mortality rate
Timepoint
End of the study
Method of measurement
Number of patients who died
5
Description
Incidence of adverse effects
Timepoint
During and following the administration of DHA until the death or hospital discharge
Method of measurement
Incidence of the adverse effect following DHA injection
6
Description
Arterial blood acidity
Timepoint
At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge.
Method of measurement
Measurement of arterial blood pH
7
Description
Heart rate
Timepoint
At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge.
Method of measurement
Heart rate monitor
Intervention groups
1
Description
Intervention group: The dihydroxyacetone (DHA) serum for injection, which is prepared in 500 cc bottles of 5% dextrose water at Shiraz University of Medical Sciences, is given intravenously to the patient who meets the inclusion criteria at a rate of 500 cc (one bottle) per hour. If the patient tolerates it and there are no life-threatening complications, the second and third 500 cc are administered. If needed, up to the maximum total volume of 2500 cc is infused for them.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hassan Hospital
Full name of responsible person
Leila Hosseini
Street address
Arkan road
City
Bojnurd
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3151 4000
Email
mohammadbagher_oghazian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Bahram Bibak
Street address
Dolat Blvd., Central Building of North Khorasan University of Medical Sciences,
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 3151 4000
Email
nkums.research@gmail.com
Web page address
https://research.nkums.ac.ir/index.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd University of Medical Sciences
Proportion provided by this source
10
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
2
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hossein Niknahad
Street address
Headquarters of Shiraz University of Medical Sciences, Zand Street, opposite Palestine Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814366
Phone
+98 71 3242 4128
Fax
Email
niknahadh@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hossein Niknahad
Proportion provided by this source
90
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Bagher Oghazian
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 3151 0000
Email
mohammadbagher_oghazian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Leila Hosseini
Position
Assistant Professor of Cardiology
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 3151 0000
Email
Hosseini1115@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Leila Hosseini
Position
Assistant Professor of Cardiology
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 3151 0000
Email
Hosseini1115@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
--
When the data will become available and for how long
--
To whom data/document is available
--
Under which criteria data/document could be used
--
From where data/document is obtainable
--
What processes are involved for a request to access data/document