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IRCT20191030045275N2 IRCT 2020-06-02 Faculty of Medicine, Tanta University Corn oil for gastric wash in acute aluminum phosphide poisoning Corn oil for gastric decontamination in acute aluminum phosphide poisoning: A randomized controlled trial 2020-06-01 anticipated 98 Complete https://irct.ir/trial/48103 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 98 identical, opaque, letter-sized envelopes. We used 2 rolls of household aluminum cooking foil that we cut into 98 sheets (of the same width as and twice the height of the envelope). We prepared 98 envelope-sized sheets of white paper and 98 envelope-sized sheets of single sided carbon paper. We wrote “Treatment A” on 49 paper sheets and “Treatment B” on the other 49 sheets. To prepare 49 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 49 Treatment A envelops the same way. We prepared 49 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 98. The carbon paper inside the envelope will transfer 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: Only participants will be masked. We will achieve this by making a letter for each medication used and masking the name of the medication. 2 Acute aluminum phosphide poisoning. Intervention 1: Control group (Sodium bicarbonate): 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, adequate hydration, and supportive treatment. Gastric decontamination will be carried out through aspiration of gastric contents via a nasogastric tube using 60 ml syringe.Then, gastric lavage will be performed using sodium bicarbonate. Intervention 2: Intervention group (Corn oil): 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, adequate hydration, and supportive treatment. Gastric decontamination will be carried out through aspiration of gastric contents via a nasogastric tube using 60 ml syringe. Then, 60 ml of corn oil will be administered following aspiration of gastric contents. 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 6 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 Dr. Fatma Elgazzar
El-Giesh Street, Medical Campus of the Faculty of Medicine, Tanta University
Tanta Egypt 31527 +20 40 3350373 fm.elgazzar@gmail.com Faculty of Medicine, Tanta University scientific Prof. Ahmad El-Ebiary
El-Giesh Street, Medical Campus of the Faculty of Medicine, Tanta University
Tanta Egypt 31527 +20 40 3350373 a.ebiary@med.tanta.edu.eg Faculty of Medicine, Tanta University Egypt ingestion of aluminum phosphide presentation to the hospital within two hours of aluminum phosphide ingestion 12 years 70 years Both vomiting within one hour after aluminum phosphide ingestion dissolving the aluminum phosphide pill(s) in water prior to ingestion ingestion of or exposure to substances other than aluminum phosphide treatment for aluminum phosphide poisoning in other medical facilities before admission pregnancy lactation T60 Toxic effect of pesticides Treatment - Drugs Treatment - Other Control group (Sodium bicarbonate): 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, adequate hydration, and supportive treatment. Gastric decontamination will be carried out through aspiration of gastric contents via a nasogastric tube using 60 ml syringe.Then, gastric lavage will be performed using sodium bicarbonate. Intervention group (Corn oil): 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, adequate hydration, and supportive treatment. Gastric decontamination will be carried out through aspiration of gastric contents via a nasogastric tube using 60 ml syringe. Then, 60 ml of corn oil will be administered following aspiration of gastric contents. 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: At the end of the hospitalization period. Method of measurement: Clinical evaluation. Duration of ventilation. Timepoint: At the end of the hospitalization period. Method of measurement: Clinical evaluation. Duration of hospital stay. Timepoint: At the end of the hospitalization period. Method of measurement: Clinical evaluation. The investigators Approved 2020-04-24 Ethics Committee of Tanta Faculty of Medicine El-Giesh Street, Medical Campus of the Faculty of Medicine, Tanta University Tanta El-Gharbia Egypt