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IRCT20220219054058N1 IRCT 2022-03-01 Arak University of Medical Sciences The effect of Hydrocortisone,Vitamin C and Thiamine in treatment of patients with severe Sepsis/Septic shock The effect of Hydrocortisone,Vitamin C and Thiamine in treatment of patients with severe Sepsis/Septic shock in ICU 2022-03-01 anticipated 50 Complete https://irct.ir/trial/62102 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Blinding description: Due to the double-blind study, in this study, patients as well as the project data analyst and the project partner intern who is responsible for completing the questionnaires will be unaware of the division of patients into two groups. 2-3 septic shock,severe sepsis. Intervention 1: Intervention group: Patients in this group receive combined three drugs of Hydrocortisone (50 mg every 6 hours intravenously - Jaber Bin Hayan Pharmaceutical Company, Iran), Thiamine (200 mg in 50 ml of normal saline every 12 hours intravenously - Pouyan daroo , Iran), Vitamin C (1500 mg every 6 hours in 100 ml of normal saline intravenously - Osweh Pharmaceutical Company, Iran) for three days in addition to standard treatment in the Intensive care unit. Intervention 2: Control group: Patients in this group receive only standard treatment in the Intensive care unit. 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 no more information
public Mobina Hosseini
postal code 3813138483, Mahdiyar alley, Shariati street, Arak, Iran
Arak Iran (Islamic Republic of) 3813138483 +98 86 3222 4617 Mobinaaahosseini@gmail.com Arak University of Medical Sciences scientific Mobina Hosseini
postal code 3813138483, Mahdiyar alley, Shariati street, Arak, Iran
Arak Iran (Islamic Republic of) 3813138483 +98 86 3222 4617 Mobinaaahosseini@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) NO covid 19 Disease(PCR negative) Age 18or higher No pregnancy No G6PD deficiency No initial diagnosis of: Stroke, Acute Coronary syndrome, Active Gastrointestinal bleeding, Burns and Trauma No use of vasopressors more than 24 hours before entering the study 18 years no limit Both R65.21 Severe sepsis with septic shock Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group receive combined three drugs of Hydrocortisone (50 mg every 6 hours intravenously - Jaber Bin Hayan Pharmaceutical Company, Iran), Thiamine (200 mg in 50 ml of normal saline every 12 hours intravenously - Pouyan daroo , Iran), Vitamin C (1500 mg every 6 hours in 100 ml of normal saline intravenously - Osweh Pharmaceutical Company, Iran) for three days in addition to standard treatment in the Intensive care unit. Control group: Patients in this group receive only standard treatment in the Intensive care unit. Mortality rate, Duration of intubation, Duration of stay in the intensive care unit, Duration of vasopressor, CRP, Lactate, Severity of illness. Timepoint: Mortality at the end of 7 days, Intubation period up to 7 days, Mean daily disease intensity up to 3 days, Mean CRP level on the first, third and fifth day, Duration of stay in intensive care unit up to 7 days, Duration of hospital stay, Mean level Lactate on the first, third and fifth day, Duration of receiving vasopressor up to 7 days. Method of measurement: Questionnaire filled out by Intern. Arak University of Medical Sciences Approved 2022-02-22 Ethics committee of Arak University of Medical Sciences Valiasr hospital,Valiasr square,Khorram street Arak Markazi Iran (Islamic Republic of)