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IRCT20200507047344N4 IRCT 2022-07-11 Esfahan University of Medical Sciences Effectiveness of Plasmaphersis on the treatment of paraquat poisoned patients Investigating the effectiveness of plasmapheresis in treatment, hemodynamic, electrolyte parameters and the outcome of paraquat poisoned patients 2022-08-22 anticipated 80 Complete https://irct.ir/trial/64490 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 80 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups, Blinding description: Due to the administration of plasmapheresis in one group and its non-administration in the other group, the intervener is aware of the type of intervention in each of the two groups. In addition, the patient is not aware of the difference in the type of treatment between the two groups. Also, the data collector and the data analyzer of the type of intervention in each group will not have any information. 3 Paraquat poisoning. Intervention 1: Control group: In this group, patients undergoing routine treatment including hemodialysis and administration of antioxidants including N-acetylcysteine 300 mg/kg 24-hour daily infusion, vitamin E 300 units every 12 hours intramuscularly, and vitamin C 200 mg/h is given as an intravenous infusion and 1 gram of methylprednisolone daily during hospitalization. The dose of vitamin C in case of kidney involvement will be changed after consultation with a nephrologist. Intervention 2: Intervention group: In this group, in addition to the routine treatment, patients are treated with plasmapheresis as follows. Plasmapheresis is a daily volume for 7 days, replaced with fresh plasma, after which plasmapheresis will be performed on alternating days as needed. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Shafeajafar Zoofaghari
Sharif vaghefi st.Behzad(9)
Isfahan Iran (Islamic Republic of) 8153797567 +98 31 3268 7610 shafeajafar@med.mui.ac.ir Esfahan University of Medical Sciences scientific Shafeajafar Zoofaghari
Sharif vaghefi st.Behzad(9)
Isfahan Iran (Islamic Republic of) 8153797567 +98 31 3268 7610 shafeajafar@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Oral paraquat poisoning (confirmation of paraquat poisoning is determined by testing for urinary sodium dithionate test) No more than 24 hours after poisoning Satisfaction to participate in the study 18 years no limit Both Having coagulation disorders Having a history of respiratory-lung diseases Having a previous lung injury Having seizures, loss of consciousness or coma T60.3X1 Toxic effect of herbicides and fungicides, accidental (unintentional) Treatment - Drugs Other Control group: In this group, patients undergoing routine treatment including hemodialysis and administration of antioxidants including N-acetylcysteine 300 mg/kg 24-hour daily infusion, vitamin E 300 units every 12 hours intramuscularly, and vitamin C 200 mg/h is given as an intravenous infusion and 1 gram of methylprednisolone daily during hospitalization. The dose of vitamin C in case of kidney involvement will be changed after consultation with a nephrologist. Intervention group: In this group, in addition to the routine treatment, patients are treated with plasmapheresis as follows. Plasmapheresis is a daily volume for 7 days, replaced with fresh plasma, after which plasmapheresis will be performed on alternating days as needed. Systolic blood pressure. Timepoint: Before the intervention and the first, third, fifth days after the intervention and during the discharge from the hospital. Method of measurement: Monitoring device. Diastolic blood pressure. Timepoint: Before the intervention and the first, third, fifth days after the intervention and during the discharge from the hospital. Method of measurement: Monitoring device. Electrolytic parameters. Timepoint: Before the intervention and the first, third, fifth days after the intervention and during the discharge from the hospital. Method of measurement: Blood test. Coagulation parameters. Timepoint: Before the intervention and the first, third, fifth days after the intervention and during the discharge from the hospital. Method of measurement: Blood test. Tachypnea. Timepoint: The first, third, fifth days after the intervention until discharge from the hospital. Method of measurement: Clinical examination. Respiratory distress. Timepoint: The first, third, fifth days after the intervention until discharge from the hospital. Method of measurement: Clinical examination. Hypocalcemia. Timepoint: The first, third, fifth days after the intervention until discharge from the hospital. Method of measurement: Clinical examination. Isfahan University of Medical Sciences Approved 2022-05-11 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib street, Azadi square. Isfahan Isfehan Iran (Islamic Republic of)