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IRCT20220711055432N1 IRCT 2022-09-10 Oroumia University of Medical Sciences Assessment of the vitamin B1 effect on the outcomes of patients with sepsis Assessment of the vitamin B1 effect on the outcomes of patients with sepsis under mechanical ventilation admitted to the general intensive care unit 2022-09-23 anticipated 56 Complete https://irct.ir/trial/64890 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention or placebo groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (56 patients), 14 blocks of 4 will be used. Patients will be allocated to intervention or placebo groups based on generated numbers, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the researcher evaluating the outcomes will be blind to the allocation of patients into intervention or placebo groups. In the first stage, none of the patients will know about their assignment to intervention or placebo groups (Vitamin B1 and placebo tablets will be similar in shape, size, and color). In the second stage, the anesthesiologist will prescribe the drug (other than the outcome assessor), so the table of computer-generated numbers will be given to the anesthesiologist. The anesthesiologist will enter the patients into groups according to the order of numbers. Finally, the name of groups will be encoded with the letters A and B. 3 Sepsis. Intervention 1: Intervention group: Patients will receive oral vitamin B1 tablets (300 mg) on the second day of mechanical ventilation for up to 7 days in addition to routine treatments. The drug will be procured from Jalinous Pharmaceutical Company. Intervention 2: Control group: Patients will receive placebo tablets (300 mg) on the second day of mechanical ventilation for up to 7 days in addition to routine treatments. The placebo will be prepared by the pharmacy faculty of Urmia university of Medical Sciences. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. Mohammad Amin Valizad Hasanlouei
Imam Khomeini hospital., Ershad Ave., Modarress Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3345 7286 valizadeh.ma@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Mohammad Amin Valizad Hasanlouei
Imam Khomeini hospital., Ershad Ave., Modarress Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3345 7286 valizadeh.ma@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Sepsis patients Patients under mechanical ventilation for at least 24 hours Age above 18 years 18 years no limit Both Renal failure with a GFR of less than 15 Vitamin B1 consumption during the last 15 days before hospitalization Hospitalization less than 4 days in ICU Having an indication for the administration of vitamin B1, such as alcohol poisoning A41 Other sepsis Treatment - Other Treatment - Other Intervention group: Patients will receive oral vitamin B1 tablets (300 mg) on the second day of mechanical ventilation for up to 7 days in addition to routine treatments. The drug will be procured from Jalinous Pharmaceutical Company. Control group: Patients will receive placebo tablets (300 mg) on the second day of mechanical ventilation for up to 7 days in addition to routine treatments. The placebo will be prepared by the pharmacy faculty of Urmia university of Medical Sciences. Duration of mechanical ventilation. Timepoint: during a week after the intervention. Method of measurement: Days. The Sequential Organ Failure Assessment (SOFA) Score. Timepoint: Before intervention and 1st, 3rd and 7th day after the intervention. Method of measurement: The Sequential Organ Failure Assessment (SOFA) index. Acute Physiology and Chronic Health Evaluation (APACHE) II score. Timepoint: Before intervention and 1st, 3rd and 7th day after the intervention. Method of measurement: Acute Physiology and Chronic Health Evaluation (APACHE) II queationnaire. White blood cell count (WBC). Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Cell counter. Erythrocyte sedimentation rate (ESR). Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Flow Cytometry. C-reactive protein (CRP). Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Elisa test. Lactate dehydrogenase (LDH). Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Elisa test. Neutrophil to lymphocyte ratio. Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Blood sample. Mortality. Timepoint: During hospitalization and 28 days after intervention. Method of measurement: Medical record/ phone call. Oroumia University of Medical Sciences Approved 2021-12-15 Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences Imam Khomeini hospital., Ershad Ave., Modarress Blvd., Urmia., Iran. Urmia West Azarbaijan Iran (Islamic Republic of)