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IRCT20190602043787N2 IRCT 2020-07-07 Mashhad University of Medical Sciences Effect of vitamin B1on septic shock patiens Effectiveness of initial administration of thiamine in patients with septic shock in patients admitted in the adult intensive care unit 2020-02-20 anticipated 70 Complete https://irct.ir/trial/42735 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization with quadruple blocks with individual units is used.it is randomization tool with opaque and sealed envelopes.permuted block randomization with quadruple blocks are used to create randomization.according to the sample size which is 70 people,20 blocks will be produced using the site www.sealedenvelope.com.hidden allocation is using opaque and sealed envelopes, Blinding description: Participants,researchers,healthcare providers (Physicians, nurses, etc.) , data collectors, data analyzer and those who evaluate the outcome , are blinded to the treatment prescribed. For the control group, placebo was prescribed which was similar in shape and color and size of the drug. 3 Septic shock. Intervention 1: Intervention group: These patients are given two 100 miligram Vitamin B1 pills that each contains 100 miligram Vitamin B1 and manufactured by Daroopakhsh/Iran, twice daily for 7 days per oral. Intervention 2: Control group: in the control group we will give placebo tablet twice daily for 7 days per oral .the placebo will be similar in color,taste,shape and administration to the intervention group, not just the therapeutic effect. 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 Zahra Ataee
Avesina Ave,Emam Reza hospital
Mashhad Iran (Islamic Republic of) 9137913316 009838543031 ataeez@mums.ac.ir Mashhad University of Medical Sciences scientific Zahra Ataee
Avesina Ave, Emam Reza hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 ataeez@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Ages over 18 years old Patients with septic shock(a patient that meets the criteria for sepsis and despite adequite fluid thrapy needs vasopressor to preserve MAP ≥ 65mmhg and serum lactate is greater than 2 mmol) Complete informed consent form in the first stage of legal guardianship and in case of failure we refer to the judge of the country Serum lactate is greater than 2 mmol/li Hypotention(systolic BP less than 90 mmhg despite adequite fluid thrapy needs vasopressor(Dopamin ≥ 5mcg/kg/min or Phenylephrine) Refusal to participate in any other intervention research project 18 years no limit Both Liver failure or dysfunction(AST OR ALT >240 unit/li or known cirrhosis) based on previous findings that patients with liver dysfunction may have increased levels of thiamine. Indication of receiving thiamine(Alcohol abuse) Other causes of increased lactate levels(seizure in 3 hours) Prescription of high-levev lactate -like drugs (Linezolid-Methformine)by your phicision Cyanide or CO poisoning Known mitochondrial disease Known or suspected ischemia of the intestine or other organs R65.21 Severe sepsis with septic shock Treatment - Drugs Placebo Intervention group: These patients are given two 100 miligram Vitamin B1 pills that each contains 100 miligram Vitamin B1 and manufactured by Daroopakhsh/Iran, twice daily for 7 days per oral. Control group: in the control group we will give placebo tablet twice daily for 7 days per oral .the placebo will be similar in color,taste,shape and administration to the intervention group, not just the therapeutic effect. Mortality within hospitalization. Timepoint: 28-day hospital mortality rate. Method of measurement: Patient mortality rate. Duration of hospitalization in Intensive Care Unit. Timepoint: From the begining to the end of admition in Intensive Care Unit. Method of measurement: Number of days. Level of serum lactate. Timepoint: At 0 and 24 hours after intervention. Method of measurement: By examining blood plasma by the method of euthoanalyzer. Illness severity. Timepoint: Information on the Acute physiology and cronic health evaluation (APACHE II) questionnaire is collected once a week and Sequential organ failure assessment ( SOFA) questionnaire is collected every other day. Method of measurement: By index Sequential organ failure assessment ( SOFA) and Acute physiology and cronic health evaluation (APACHE II ) questionnaire. Level of serum thiamine. Timepoint: At 0 hours after intervention. Method of measurement: High-performance liquid Chromatography(HOLC) with normal reference range 16-48 ng/ml. Mashhad University of Medical Sciences Approved 2020-02-01 Ethics committee of Mashhad University of Medical Sciences Quraish bilding of MUMS, daneshghah St, Mashhad, Iran Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)