Evaluation the effect of adding Sevelamer to the standard treatment of aluminum phosphide poisoning patients, referred to Tehran's Luqman Hospital, a preliminary studyon mortalit
investigate the effectiveness of adding sevelamer and standard treatment on the mortality rate and treatment of aluminum phosphide poisoning patients.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized using the Random Number Generator v1.4 program - phase 2 on 60 patients
Settings and conduct
In this randomized clinical trial study, among the patients who have been poisoned with aluminum phosphide 60 people entered the study and were randomly assigned to two groups of 30 people by random allocation software. All the patients included in the study were in the age group of 18-60 years who were poisoned by oral form and arrived at Loqhman Hospital within 24 hours of consuming aluminum phosphide.
Participants/Inclusion and exclusion criteria
inclusion Criteria: consumption of oral form of aluminum phosphide and visit to Loqman Hospital within 24 hours and the presence of symptoms consistent with poisoning, positive silver nitrate test and carbon monoxide measurement above 10 in non-smokers.Non-entry conditions: glomerular filtration rate less than 30, history of kidney failure, history of liver failure, history of acute myocardial infarction, history of congenital heart disease, history of heart failure during pregnancy and breastfeeding, referral after 24 hours of taking rice tablets.
Intervention groups
Intervention group: Aluminum phosphide poisoning patients who receive standard treatment and sevelamer at first 2.4 grams of sevelamer carbonate and then two 800 mg tablets of sevelamer carbonate every 8 hours, which continues until the death or recovery of the patient. Control group : Aluminum phosphide poisoning patients receiving standard treatment until recovery or death.
Main outcome variables
Patient outcome - duration of hospitalization - intubation - duration of intubation- CO2 pressure - O2 pressure - PH - heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210720051946N7
Registration date:2024-04-03, 1403/01/15
Registration timing:registered_while_recruiting
Last update:2024-04-03, 1403/01/15
Update count:0
Registration date
2024-04-03, 1403/01/15
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
2024-03-20, 1403/01/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of adding Sevelamer to the standard treatment of aluminum phosphide poisoning patients, referred to Tehran's Luqman Hospital, a preliminary studyon mortalit
Public title
Evaluation the effect of adding Sevelamer to the standard treatment of aluminum phosphide poisoning patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Taking the oral form of aluminum phosphide
Referral to Luqman Hospital within 24 hours
The presence of symptoms consistent with poisoning
Positive silver nitrate test
Carbon monoxide measurement above 10 in non-smokers
Exclusion criteria:
glomerular filtration rate less than 30
History of kidney failure
History of liver failure
History of acute myocardial infarction
History of congenital heart disease
History of heart failure during pregnancy and breastfeeding
Referral after 24 hours of taking rice tablets
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using the Random Number Generator v1.4 computer program, so that as soon as the patient enters the relevant department, a random number between 1 and 60 will be requested, which will be assigned to the patient if the patient has an even number. He will be included in the control group and if the patient has an odd number, he will be included in the study group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each dose of medicine is individually packaged and has an identification number. Drug and placebo boxes are supplied in completely similar appearance and packaging, which will cause blinding of participants, researchers and outcome assessors.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti Medical University
Street address
Shahid beheshti medical university,Arabi ST,Daneshjou Blvd,Velenjak,Tehran
City
Tehran
Province
Tehran
Postal code
193954631
Approval date
2024-02-26, 1402/12/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.712
Health conditions studied
1
Description of health condition studied
Aluminum phosphide poisoning
ICD-10 code
Y19
ICD-10 code description
Poisoning by and exposure to other and unspecified chemicals and noxious substances, undetermined intent
Primary outcomes
1
Description
Prognosis of patients poisoned with aluminum phosphide tablets referred to Luqman Hakim Hospital
Timepoint
Length of hospitalization
Method of measurement
Days
Secondary outcomes
1
Description
Mortality
Timepoint
Patient death or patient survival
Method of measurement
Yes or no
Intervention groups
1
Description
Intervention group: sevelamer, in addition to routine treatment, 2 tablets of 800 mg every 8 hours
Category
Treatment - Drugs
2
Description
Control group: Receiving standard aluminum phosphide treatment without receiving sevelamer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Kiandokht Khorshidi
Street address
Loghman hakim hospital,Makhsous Ave,District 10,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Chamran Highway - Yemen Street - Shahid Abbas Arabi Street (Parvaneh) - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences and Healthcare Services - Headquarters Building 2- 5th floor - Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 2243 9780
Email
info@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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfantalab Avini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
Peyman1346erfan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfantalab Avini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
Peman1346efran@smu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfantalab Avini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Fax
Email
Peyman1346erfan@sbmu.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
Always available
To whom data/document is available
All researchers
Under which criteria data/document could be used
Do more research
From where data/document is obtainable
Loqhman Hakim Hospital - Poisoning Research Center
What processes are involved for a request to access data/document