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IRCT20201116049410N1 IRCT 2021-07-14 Esfahan University of Medical Sciences Effect of treatment with (Hydrocortisone+ Ascorbic acid+ Neurobion)on multiple trauma patients Evaluation of treatment with (Hydrocortisone+ Ascorbic acid+ Neurobion) on the prognosis of multiple trauma patients in comparison with control group 2021-09-22 anticipated 70 Complete https://irct.ir/trial/52767 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by simple randomization method. To do this, 70 prepared cards are written on 35 letters of letter A and on 35 other Tides of letter B and the cards are thrown into the box and shuffled well. When each patient enters the intensive care unit, one of the nurses who is not awar about the study, is asked to bring out a card. According to what is written on the card, patients are placed in the intervention or control group, Blinding description: The study is a three-blind study and patients, researchers and outcome evaluators are unaware of the type of combination received. The drug combination of the two groups in similar packages is prepared by one of the personnel of the intensive care unit who is not under study and is provided to the executor of the project for use. 3 multiple trauma. Intervention 1: Intervention group: Patients in this group receive 1.5 g of vitamin C every 6 hours for 4 days, hydrocortisone 50 mg every 6 hours for 7 days, neurobion two ampoules every 12 hours for 4 days. Intervention 2: Control group: Patients in this group receive a placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is The plan belongs to a government agency and cannot be shared.
public Arash Masoudpour
ِDepartment of Anesthesiology, Alzahra hospital, Soffeh street
Isfahan Iran (Islamic Republic of) 8434193474 36692174 arash1360@gmail.com Esfahan University of Medical Sciences scientific Seyed Taghi Hashemi
Department of Anesthesiology, Alzahra hospital, Soffeh street
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3669 2174 st_hashemi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Adult patient (age ≥ 18 years) Multiple trauma patients Injury Severity Score greater than 15 18 years no limit Both Pregnancy History of adrenal insufficiency Patients with history of Immunosuppression Corticosteroid therapy within the last six months G6PD patients Hhistory of oxalate nephropathy Oliguria or anuria Known allergy to vitamin C, hydrocortisone, neurobion T07 Unspecified multiple injuries Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group receive 1.5 g of vitamin C every 6 hours for 4 days, hydrocortisone 50 mg every 6 hours for 7 days, neurobion two ampoules every 12 hours for 4 days. Control group: Patients in this group receive a placebo General condition of the patient. Timepoint: Every day. Method of measurement: SOFA score. Duration of hospitalization in the intensive care unit. Timepoint: At the time of leaving the Border Special Cases section. Method of measurement: The time interval between entering and leaving the intensive care unit. Ventilation time. Timepoint: One time, at the extubation time. Method of measurement: Calculate the number of days connected to the ventilator. Prognosis of the disease. Timepoint: Time to leave the intensive care unit. Method of measurement: Determining the patient's recovery status or death. Esfahan University of Medical Sciences Approved 2020-10-14 Ethics committee of Isfahan University of Medical Sciences َAyatollah Kashani street Isfahan Isfehan Iran (Islamic Republic of)