Increasing the survival rate of patients with aluminum phosphide poisoning
Design
This study will be conducted as a randomized, controlled, open-label, parallel group assignment clinical trial, on 40 patients (20 patients in each group) in Loghman Hakim hospital.
Settings and conduct
Patients referred to the emergency department of Loghman Hospital with aluminum phosphide poisoning are included in the study according to the inclusion criteria and will receive standard treatment. A group of patients will also receive intravenous L-carnitine in addition to the standard treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
aluminum phosphide intoxication,
Positive silver nitrate test,
Systolic blood pressure lower than 90 mmHg,
Serum bicarbonate less than 15 mEq/L,
Blood pH lower than 7.2,
Cardiac output of 15 and above
Exclusion criterion:
Patients or caregivers who have not provided written informed consent
Intervention groups
The patients are divided into two groups of control and test, both of which receive standard care (including a vasopressor, sodium bicarbonate or potassium permanganate and GIK protocol) and the test group, in addition to standard treatment, will receive 1 gram of L-carnitine intravenously every 8 hours.
Main outcome variables
Assessment of 24-hour mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210720051946N1
Registration date:2022-04-20, 1401/01/31
Registration timing:retrospective
Last update:2022-04-20, 1401/01/31
Update count:0
Registration date
2022-04-20, 1401/01/31
Registrant information
Name
Peyman Erfan Talab Evini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5000
Email address
peyman1346erfan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Intravenous Levocarnitine on the mortality and morbidity of patients with aluminum phosphide intoxication
Public title
Assessment of Intravenous Levocarnitine on the mortality and morbidity of patients with aluminum phosphide intoxication
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
aluminum phosphide intoxication
Positive silver nitrate test
Systolic blood pressure lower than 90 mmHg
Serum bicarbonate less than 15 mEq/L
Blood pH lower than 7.2
Cardiac output of 15 and above
Exclusion criteria:
Patients or caregivers who do not provide written informed consent
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization, meaning: codes A and B are written on pre-prepared forms and the forms will be taken and used randomly. The patient for whom code A is assigned will receive L-carnitine and the ones with code B will not receive L-carnitine.
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 Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
13th Floor, Block A, Headquarters of the Ministry of Health, Treatment and Medical Education, Sima-ye-Iran street, Between South Flamek and Zarafshan St
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.273
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
24-hour mortality
Timepoint
assessment of death within 24 hours after arrival to the hospital
Method of measurement
patient medical record
Secondary outcomes
1
Description
Peripheral blood pH
Timepoint
every three hours
Method of measurement
Venous blood gas
2
Description
Peripheral Blood HCO3
Timepoint
every three hours
Method of measurement
Venous blood gas
3
Description
Blood pressure
Timepoint
every three hours
Method of measurement
sphygmomanometer
4
Description
Vasopressor administration
Timepoint
every three hours
Method of measurement
Patient medical record
Intervention groups
1
Description
Intervention group: L-Carnitine 1 gram every 8 hours intravenously with standard care
Category
Treatment - Drugs
2
Description
Control group: Standard care (a vasopressor with sodium bicarbonate or potassium permanganate and the GIK protocol (glucose, insulin, potassium)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Dr Peyman Erfantalab Evini
Street address
Loghman Hospital kamali st. Kargar st. Tehran. Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
peyman1346erfan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Peyman Erfantalab
Street address
Lashgar Intersection, Makhsous St., Loghman hakim hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
peyman1346erfan@sbmu.ac.ir
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
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
Alborz university of medical sciences
Full name of responsible person
Dr Hoorvash Farajidana
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Forensic Medicine
Street address
Alborz University of Medical Sciences, North Taleghani Boulevard, Karaj - Taleghani Square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
hoorvash88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfan Talab Evini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Loghman Hospital kamali st. Kargar st. Tehran. Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Fax
Email
peyman1346erfan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Alborz university of medical sciences
Full name of responsible person
Dr Hoorvash Farajidana
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Forensic Medicine
Street address
Alborz University of Medical Sciences, North Taleghani Boulevard, Karaj - Taleghani Square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
hoorvash88@gmail.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