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IRCT20211017052794N1 IRCT 2022-04-13 Shahid Beheshti University of Medical Sciences Investigation of the effect of Trimetazidine in patients with Aluminum phosphide poisoning Evaluation of the effect of adding Trimetazidine to standard treatment of patients with Aluminum phosphide poisoning,referal to Loghman Hospital In TehranĜŒ a pilot study on mortality 2022-09-22 anticipated 30 Complete https://irct.ir/trial/62444 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, block random sampling method will be used. In the present study, 2 groups are studied (intervention group and control group) Therefore, quadruple blocks will be used. According to the calculated sample size (total number of 30 people who are divided into two groups of 15 people). 8 quadruple blocks will be considered. Random assignment of individuals to the groups under study will be done in this way. First, 15 envelopes containing four cards with A, B, C, D Latin letters were prepared, letters A and B = intervention group, letters C and D = as control group. According to the inclusion criteria, they were asked to The 30 sealed envelopes randomly selected one and randomly selected a card from within that the card label determined the assignment of the individual to each of the two study groups, Blinding description: In this study, patients are unaware of the drug allocation, in fact, the patient does not know whether he is receiving Trimetazidine in addition to standard treatment or only under standard treatment. Before starting the drug. Explain to each patient or their first-degree family Will be given to enter a clinical trial study with written consent and informed consent. The nurses responsible for administering the medication are in the process of designing the study but are unaware of the interventions and objectives under study but Internal medicine specialists, toxicologists and cardiologists are aware of this issue. 3 Patients with Aluminum phosphide poisoning. Intervention 1: Biogaran tablets with the chemical composition of Trimetazidine, 35 mg, which is used orally every 12 hours for 5 days. This drug is made by the French company Biogaran. During this 5-day period and other days of hospitalization , patients are closely monitored and all variables are checked and charted. Intervention 2: Intervention group:In this group of 15 patients, the identified patients are treated with Trimetazidine 35 mg tablet from Biogaran Pharmaceutical Company for 5 days, every 12 hours, and during this period of 5 days and other days of hospitalization, the desired variables are monitored and examined and the information is charted. Intervention 3: Control group: In this group of 15 patients, all patients receive only standard treatment while hospitalized and are not treated with Trimetazidine tablets. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the pilot nature of the study and the small number of patients, there is still no decision to publish it
public Mehdi Sheibani
Erabi street-Velenjak
Tehran Iran (Islamic Republic of) 99877777765 +98 21 5102 5000 mesheibani@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mehdi Sheibani
Makhsos street
Tehran Iran (Islamic Republic of) 1984845497 +98 21 5102 5000 mesheibani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Consumption of oral form of Aluminium phosphide and referrs to Loghman Hospital under 24 hours and the presence of symptoms consistent with poisoning Positive silver nitrate test Carbon monoxide levels above 10 in non-smokers 18 years 60 years Both Glomerular Filtration Rate(GFR) less than 30 (if available ),history of renal failure , history of liver failure , history of acute myocardial infarction, history of heart failure, history of congenital heart disease Pregnancy and lactation Refer to hospital after 24 hours T50.901 Poisoning by unspecified drugs, medicaments and biological substances, accidental (unintentional) Treatment - Drugs Treatment - Drugs Treatment - Drugs Biogaran tablets with the chemical composition of Trimetazidine, 35 mg, which is used orally every 12 hours for 5 days. This drug is made by the French company Biogaran. During this 5-day period and other days of hospitalization , patients are closely monitored and all variables are checked and charted. Intervention group:In this group of 15 patients, the identified patients are treated with Trimetazidine 35 mg tablet from Biogaran Pharmaceutical Company for 5 days, every 12 hours, and during this period of 5 days and other days of hospitalization, the desired variables are monitored and examined and the information is charted. Control group: In this group of 15 patients, all patients receive only standard treatment while hospitalized and are not treated with Trimetazidine tablets. Mortality. Timepoint: During hospitalization. Method of measurement: Death during admission. Admit duration. Timepoint: Period of time. Method of measurement: Daily chart. Icu admission. Timepoint: Number of hospitalization days. Method of measurement: Daily chart. Arrhythmia. Timepoint: Daily electrocardiogram/As long as the patient is being treated with trimetazidine. Method of measurement: Electrocardiogram. Need for inotropic drugs. Timepoint: Number of hospitalization days. Method of measurement: Based on blood pressure less than 90 mmHg and inotrop drugs initiation recorded in the chart. Left ventricle ejection fraction. Timepoint: Second day of admission. Method of measurement: Echocardiography. Intubation. Timepoint: Hospital admission. Method of measurement: Number of intubation patients registered in the chart. Shahid Beheshti University of Medical Sciences Approved 2022-03-11 Shahid Beheshti University of Medical Sciences Velenjak - Daneshjoo Boulevard - Shahid Beheshti Faculty of Medical Sciences Tehran Tehran Iran (Islamic Republic of)