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IRCT20200724048192N1 IRCT 2020-08-30 Menoufia Faculty of Medicine Antioxidants in acute aluminum phosphide poisoning N-acetylcysteine as an adjuvant therapy in acute aluminum phosphide poisoning: A randomized clinical trial 2020-09-01 anticipated 48 Complete https://irct.ir/trial/49912 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We used the sealed, opaque sequentially numbered envelopes method for randomization and allocation concealment of patients included in this trial as described by Doig and Simpson (2005). We used 48 identical, opaque, letter-sized envelopes. We used 2 rolls of household aluminum cooking foil that we cut into 48 sheets (of the same width as and twice the height of the envelope). We prepared 48 envelope-sized sheets of white paper and 48 envelope-sized sheets of single sided carbon paper. We wrote “Treatment A” on 24 paper sheets and “Treatment B” on the other 24 sheets. To prepare 24 Treatment A envelops, we selected one envelope-sized sheet of of Treatment A and placed one sheet of carbon paper on top of the Treatment A allocation paper with the carbon side facing the paper, then we put both papers inside a foil wrapper. Then, the completed insert was placed into a blank envelope with the carbon paper closest to the front of the envelope. Finally, the envelop was sealed and we signed across the seal. We completed all the 24 Treatment A envelops the same way. We prepared 24 Treatment B envelops the same way as Treatment A envelops. Both sets of envelops were combined and we shuffled them thoroughly. Then, using a pen we marked a number on the front of each envelope sequentially from 1 to 48. The carbon paper inside the envelope transferred this number to the allocation paper inside. Finally, we placed these envelopes into a plastic container, in numerical order, ready for use. Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care 2005;20:187–93, Blinding description: Participants & data analyzers will be blinded. We will achieve this by making a letter for each medication used and masking the name of the medication & masking the intervention groups (data will be presented to data analyzers as groups A and B. 2 Acute aluminum phosphide poisoning. Intervention 1: Control group: Patients will receive the standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination, and supportive treatment (sodium bicarbonate, inotropes, intravenous fluids, electrolytes, intubation, mechanical ventilation, and anti-arrhythmic agents as indicated). Intervention 2: Intervention group: Patients will receive the standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination, and supportive treatment (sodium bicarbonate, inotropes, intravenous fluids, electrolytes, intubation, mechanical ventilation, and anti-arrhythmic agents as indicated). In addition, N-acetyl cysteine will be administered as 150 mg/kg (in 200 ml 5% dextrose) by intravenous infusion over 1 hour, followed by 50 mg/kg (in 500 ml 5% dextrose) over 4 hours, then 100 mg/kg (in 500 ml 5% dextrose) over 16 hours. We will use this form of N-acetyl cysteine: ROTACYSTEINE 20% (IV-INFU) 25 ml/vial, produced by Rotabiogen for Pharmaceuticals Invest for Arabcomed-Egypt. Each package contains one vial (25 ml) each 1 ml contains 200 mg of N-acetyl cysteine. Yes - There is a plan to make this available What will be shared: We plan to share all IPD that underlie results When: Data will become available 12 months and ending 36 months following article publication To whom: Researchers from academic institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose Conditions: For IPD meta-analysis Where to obtain: Data will be obtainable from the PI How to obtain: A proposal for the use of data to be submitted to the PI, then evaluated by an independent review committee identified for this purpose Comments:
public Soha Hamid
sabry abo alam
shebin el kom Egypt 32511 +20 48 2052265 d_sh_2007@yahoo.com Menoufia University Faculty of Medicine scientific Soha Abdel khalek
El Kom St., Shibin El Koum - Menoufia - Egypt
shebin el kom Egypt 32511 +20 48 2233463 soha_abdelkhalek@med.menofia.edu.eg Menoufia Faculty of Medicine Menoufia University Egypt History of taking aluminum phosphide tablet(s) and clinical manifestations of acute aluminum phosphide poisoning Reliable identification of the compound either by the container brought by patient attendants or subsequent confirmation with positive silver nitrate test on gastric sample in case of oral route exposure 12 years no limit Both Patients less than 12 years old Pregnant and lactating women Patients suffering from chronic diseases (e.g. diabetes mellitus, cardiovascular diseases, and hepatic or renal failure) Tablet(s) was/were dissolved in water before ingestion Ingestion of air-exposed aluminium phosphide tablets Time passed since ingestion more than 8 hours Patient who refused to participate T60 Toxic effect of pesticides Treatment - Drugs Treatment - Drugs Control group: Patients will receive the standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination, and supportive treatment (sodium bicarbonate, inotropes, intravenous fluids, electrolytes, intubation, mechanical ventilation, and anti-arrhythmic agents as indicated). Intervention group: Patients will receive the standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination, and supportive treatment (sodium bicarbonate, inotropes, intravenous fluids, electrolytes, intubation, mechanical ventilation, and anti-arrhythmic agents as indicated). In addition, N-acetyl cysteine will be administered as 150 mg/kg (in 200 ml 5% dextrose) by intravenous infusion over 1 hour, followed by 50 mg/kg (in 500 ml 5% dextrose) over 4 hours, then 100 mg/kg (in 500 ml 5% dextrose) over 16 hours. We will use this form of N-acetyl cysteine: ROTACYSTEINE 20% (IV-INFU) 25 ml/vial, produced by Rotabiogen for Pharmaceuticals Invest for Arabcomed-Egypt. Each package contains one vial (25 ml) each 1 ml contains 200 mg of N-acetyl cysteine. All-cause mortality during hospital admission. Timepoint: At the end of the hospitalization period. Method of measurement: Clinical assessment. Proportion of patients requiring intubation. Timepoint: Before the intervention and one day after completion of the intervention. Method of measurement: Clinical evaluation. Duration of ventilation. Timepoint: Before the intervention and one day after completion of the intervention. Method of measurement: Clinical evaluation. Duration of hospitalization. Timepoint: At the end of the hospitalization period. Method of measurement: Clinical evaluation. Menoufia Faculty of Medicine Approved 2019-05-26 Research Ethical Committee of Faculty of Medicine, Menoufia University. Yaseen Abdelghafar St shebin el kom Menoufia Egypt