Evaluation of the efficacy of plasmapheresis in comparison with conventional treatment on electrolyte and coagulation parameters in patients poisoned with aluminum phosphide
Determining the efficacy of plasmapheresis in the treatment and outcome of patients poisoned with aluminum phosphide
Design
Non-randomized, Controlled, Single-blinding clinical trial, with the parallel groups, Phase 2-3 on 60 patients
Settings and conduct
In this study, 60 patients with aluminum phosphide poisoning from the poisoning ward of Khorshid hospital in Isfahan will be included in the study and will be randomly divided into two groups. In one group only the routine treatment will be used and in the second group in addition to the routine treatment, plasmapheresis will be used. Given the single-blinding of this study, the specialist and the patient are aware of the type of intervention, but the person who examines the patient and the data analyzer will not be aware of the type of intervention received by each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aluminum phosphide poisoning, aged between 20 and 65 years, patient/attendant consent to participate in the study. Non-inclusion criteria: any risk of coagulation disorders, a history of chronic renal failure.
Intervention groups
Control group: Patients in this group will receive only routine treatment. Continuous injection of normal saline and dopamine will be done along with olive oil gavage. In addition, intravenous administration of vitamin C, notch (NAC), magnesium sulfate, and calcium gluconate will be performed according to the usual protocol.
Intervention group: Patients in this group will undergo plasmapheresis in addition to routine treatment mentioned in the control group.
Evaluation of the efficacy of plasmapheresis in comparison with conventional treatment on electrolyte and coagulation parameters in patients poisoned with aluminum phosphide
Public title
The efficacy of plasmapheresis in the treatment of patients poisoned with aluminum phosphide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 20 and 65 years
Poisoned with aluminum phosphide
Patient/attendant consent to participate in the study
Exclusion criteria:
Any risk of coagulation disorders
History of chronic kidney failure
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that in this study, one group of patients will receive the usual treatment and the other group will also undergo plasmapheresis, so the specialist and the patient are aware of the type of intervention, but the person who examines the patient's condition and the data analyst will not be aware of the type of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib street, Azadi square.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-08, 1399/08/18
Ethics committee reference number
IR.MUI.MED.REC.1399.699
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
Systolic blood pressure
Timepoint
Immediately upon arrival at the hospital and every hour to 6 hours after the intervention
Method of measurement
Sphygmomanometer
2
Description
ِDiastolic blood pressure
Timepoint
Immediately upon arrival at the hospital and every hour to 6 hours after the intervention
Method of measurement
Sphygmomanometer
3
Description
Creatinine
Timepoint
Immediately upon arrival at the hospital and 12 hours after the intervention
Method of measurement
Blood test
4
Description
Sodium
Timepoint
Immediately upon arrival at the hospital and 12 hours after the intervention
Method of measurement
Blood test
5
Description
Magnesium
Timepoint
Immediately upon arrival at the hospital and 12 hours after the intervention
Method of measurement
Blood test
6
Description
Platelets
Timepoint
Immediately upon arrival at the hospital and 12 hours after the intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients in this group will receive only routine treatment. Continuous injection of normal saline and dopamine will be done along with olive oil gavage. In addition, intravenous administration of vitamin C at a dose of 150 mg/h, notch (NAC) at a dose of 300 mg/kg in 24 hours, 1 g magnesium sulfate and 1 g calcium gluconate every 6 hours. Vitamin E will also be given intramuscularly at a dose of 300 units every 12 hours.
Category
N/A
2
Description
Intervention group: Patients in this group will undergo plasmapheresis in addition to routine treatment. This treatment will be performed for 3 hours in the first 6 hours of the visit and the patient's plasma will be replaced with an approximate amount of 2 to 3 liters of plasmapheresis.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Shafeajafar Zoofaghari
Street address
Ostandari street.
City
Isfahan
Province
Isfehan
Postal code
81458-31451
Phone
+98 31 3222 2127
Fax
+98 31 3222 2255
Email
toxicology@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shafeajafar Zoofaghari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Emergency Medicine
Street address
No. 9, Behzad alley, Sharif Vaqefi street
City
Isfahan
Province
Isfehan
Postal code
8153797567
Phone
+98 31 3268 7610
Email
shafeajafar@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shafeajafar Zoofaghari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Emergency Medicine
Street address
No. 9, Behzad alley, Sharif Vaqefi street
City
Isfahan
Province
Isfehan
Postal code
8153797567
Phone
+98 31 3268 7610
Email
shafeajafar@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shafeajafar Zoofaghari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Emergency Medicine
Street address
No. 9, Behzad alley, Sharif Vaqefi street
City
Isfahan
Province
Isfehan
Postal code
8153797567
Phone
+98 31 3268 7610
Email
shafeajafar@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD