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IRCT138803031187N2 IRCT 2014-12-17 Vice Chancellor for Research, Mashhad University of Medical Sciences (MUMS) Studying administration of sodium bicarbonate and magnesium sulfate in clinical betterment of acute organophosphorous pesticide poisoning. Comparing therapeutic effects of sodium bicarbonate with magnesium sulfate in moderate and severe acute organophosphorous pesticide poisoning. 2008-06-21 anticipated 120 Complete https://irct.ir/trial/388 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: All patients who meet our including criteria, regardless of whether they will be put into the control or study groups, will be asked to confirm the informed consent. Besides, the principle researcher who is responsible for investigating the study's variables is totally different from the therapists who allocate the patients into the four groups, based on the two last digit of their dossiers' number (randomized numbers chart) , resulting in the project being double blind. 3 Moderate and severe acute Organophosphorous pesticide poisoning. Intervention 1: ّFirst intervention group: Intravenous infusion of 6 to 12 Sodium Bicarbonate (Pasteur Institute) 7.5% 50 ML Bags in every 24 hours for the first 3 days of hospitalization, aiming at arterial pH between 7.45 and 7.55. Intervention 2: Second intervention group: Intravenous infusion of Magnesium Sulfate (Samen Corporation) 20% 10 ML Vial, 4 grams in 4 hours, in the very beginning of admission. Intervention 3: Third intervention group: Intravenous infusion of 6 to 12 Sodium Bicarbonate (Pasteur Institute) 7.5% 50 ML Bags in every 24 hours for the first 3 days of hospitalization, aiming at arterial pH between 7.45 and 7.55 and intravenous infusion of Magnesium Sulfate (Samen Corporation) 20% 10 ML Vial, 4 grams in 4 hours, in the very beginning of admission. Intervention 4: Control (forth) group: Merely the conventional treatment. No supplementary treatment.
public Reza afshari, M.D.
Imam Reza Hospital, Imam Reza Sq., Ebn-E-Sina St.
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3859 8973 afsharir@mums.ac.ir Medical Toxicology Center and Addiction Research Center, Mashhad University of Medical Sciences scientific Seyedmahyar Mohammadi
Imam Reza Hospital, Imam Reza Sq., Ibn-E-Sina St.
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3859 8973 mahyar.mohamadii@gmail.com Medical Toxicology Center and Addiction Research Center, Mashhad University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: All patients aged 14 to 65 years old with moderate and severe acute organophosphorous pesticide poisoning referring to Imam Reza Hospital, Mashhad, Iran who or whose guardian has confirmed the relevant informed consent. Exclusion criteria: Any evidence of conductive heart diseases and myocardial injuries (inspected by Electrocardiography and plasma Troponin, every 12 hours respectively); renal dysfunction (less than 100 ML urine output for every 4 hours); concurrent administration of Digitals or Central Nervous System suppressors or Neuromuscular Junction blockers (through patients' drug history); any manifestation of magnesium intoxication (through physical examination every 2 hours while administrating magnesium sulfate). 14 years 65 years Both T60.0 Organophosphorous and Carbamate insecticides Treatment - Drugs Treatment - Drugs Treatment - Drugs N/A ّFirst intervention group: Intravenous infusion of 6 to 12 Sodium Bicarbonate (Pasteur Institute) 7.5% 50 ML Bags in every 24 hours for the first 3 days of hospitalization, aiming at arterial pH between 7.45 and 7.55. Second intervention group: Intravenous infusion of Magnesium Sulfate (Samen Corporation) 20% 10 ML Vial, 4 grams in 4 hours, in the very beginning of admission. Third intervention group: Intravenous infusion of 6 to 12 Sodium Bicarbonate (Pasteur Institute) 7.5% 50 ML Bags in every 24 hours for the first 3 days of hospitalization, aiming at arterial pH between 7.45 and 7.55 and intravenous infusion of Magnesium Sulfate (Samen Corporation) 20% 10 ML Vial, 4 grams in 4 hours, in the very beginning of admission. Control (forth) group: Merely the conventional treatment. No supplementary treatment. The dosage of Atropine administered for patients' Atropinization. Timepoint: In the first day of admission. Method of measurement: In scale of milligrams and according to the notes of patients' dossiers. Hospitalization duration. Timepoint: At the end of hospitalization. Method of measurement: In scale of days and according to the notes of patients' dossiers. Necessity to the Intensive Care Unit. Timepoint: Every morning and at the end of hospitalization. Method of measurement: According to the notes of patients' dossiers. Necessity to mechanical ventilation. Timepoint: Every morning and at the end of hospitalization. Method of measurement: According to the notes of patients' dossiers. Necessity to administrating Benzodiazepines. Timepoint: Every 12 hours and at the end of hospitalization. Method of measurement: According to the notes of patients' dossiers. Seizure incidence. Timepoint: Every day and at the end of hospitalization. Method of measurement: According to the notes of patients' dossiers. Patients' outcome. Timepoint: At the end of hospitalization. Method of measurement: According to the notes of patients' dossiers, based on whether discharged with no organophosphorous poisoning complications, discharged with some organophosphorous poisoning complications and death. Arterial blood pH. Timepoint: Every 12 hours. Method of measurement: Arterial blood pH measurement by pH meter. Vice Chancellor for Research, Mashhad University of Medical Sciences (MUMS) Approved 2007-02-13 University Ethics Committee, Mashhad University of Medical Sciences (MUMS) Mashhad University of Medical Sciences central office, Daneshgah St. Mashhad Iran (Islamic Republic of)