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      Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock : The VITAMINS Randomized Clinical Trial

      1 , 2 , 1 , 3 , 4 , 5 , 6 , 1 , 7 , 1 , 8 , 9 , 10 , 11 , 12 , 13 , 13 , 1 , 14 , 1 , 15 , 16 , 4 , 4 , 4 , 7 , 17 , 1 , 7 , 18 , 7 , 19 , 1 , 7 , 8 , 8 , 20 , 11 , 11 , 11 , 14 , 14 , 1 , 9 , 1 , 7 , 9 , for the VITAMINS Trial Investigators
      JAMA
      American Medical Association (AMA)

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          Abstract

          <p class="first" id="d15809857e476">It is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock. </p>

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          Most cited references10

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          Hospital deaths in patients with sepsis from 2 independent cohorts.

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            Thiamine deficiency in critically ill patients with sepsis.

            The objective of the study was to determine the prevalence of absolute thiamine deficiency (TD) in critically ill patients with sepsis and to examine the association between thiamine levels and lactic acidosis. This was a prospective, observational study. The setting was an urban, tertiary care center with approximately 50,000 emergency department visits per year and intensive care units numbering approximately 50 total beds. Thirty study patients admitted with clinical suspicion of infection and evidence of tissue hypoperfusion, as defined by a lactic acid level greater than 4 mmol/L or hypotension (systolic blood pressure <90 mm Hg) requiring vasopressor support, were enrolled. A control group of 30 patients presenting to the emergency department with minor emergencies was also enrolled. There were no interventions. Plasma thiamine levels were measured at 0, 24, 48, 72, and 162 hours for patients in the study group. Absolute TD was defined as less than or equal to 9 nmol/L derived from established abnormal ranges per Quest laboratory. In the study group, 3 (10%) of 30 had absolute TD upon presentation; and an additional 3 patients (6/30, 20%) developed TD within 72 hours. None of the 30 controls (0/30, 0%) exhibited absolute TD. Of the vasopressor-dependent population, 7.7% (2/26) displayed TD on presentation. For the group overall, there was no correlation between thiamine and lactic acidosis. However, in patients without liver dysfunction, thiamine was statistically significantly negatively correlated with lactic acidosis (r = -.50; P = .02). The relationship between thiamine and lactic acidosis held after multivariable regression analysis controlling for age, sex, and comorbid disease (P < .02). These preliminary findings indicate that critically ill patients may present with TD or develop this deficiency during their acute illness. We also identified a potential association between thiamine levels and lactic acidosis in patients without significant liver injury. Copyright © 2010 Elsevier Inc. All rights reserved.
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              Procurement of shared data instruments for Research Electronic Data Capture (REDCap).

              REDCap (Research Electronic Data Capture) is a web-based software solution and tool set that allows biomedical researchers to create secure online forms for data capture, management and analysis with minimal effort and training. The Shared Data Instrument Library (SDIL) is a relatively new component of REDCap that allows sharing of commonly used data collection instruments for immediate study use by research teams. Objectives of the SDIL project include: (1) facilitating reuse of data dictionaries and reducing duplication of effort; (2) promoting the use of validated data collection instruments, data standards and best practices; and (3) promoting research collaboration and data sharing. Instruments submitted to the library are reviewed by a library oversight committee, with rotating membership from multiple institutions, which ensures quality, relevance and legality of shared instruments. The design allows researchers to download the instruments in a consumable electronic format in the REDCap environment. At the time of this writing, the SDIL contains over 128 data collection instruments. Over 2500 instances of instruments have been downloaded by researchers at multiple institutions. In this paper we describe the library platform, provide detail about experience gained during the first 25months of sharing public domain instruments and provide evidence of impact for the SDIL across the REDCap consortium research community. We postulate that the shared library of instruments reduces the burden of adhering to sound data collection principles while promoting best practices. Copyright © 2012 Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                JAMA
                JAMA
                American Medical Association (AMA)
                0098-7484
                January 17 2020
                Affiliations
                [1 ]Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
                [2 ]Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine, Kyoto, Japan
                [3 ]Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
                [4 ]Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand
                [5 ]Medical Research Institute of New Zealand, Wellington, New Zealand
                [6 ]Department of Anaesthesia and Pain Medicine, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand
                [7 ]Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia
                [8 ]Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia
                [9 ]University of Melbourne, Parkville, Victoria, Australia
                [10 ]Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville, Australia
                [11 ]Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia
                [12 ]Clinical School of Medicine, University of New South Wales, Sydney, Australia
                [13 ]Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil
                [14 ]Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia
                [15 ]Intensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, Victoria, Australia
                [16 ]School of Medicine, Deakin University, Waurn Ponds, Victoria, Australia
                [17 ]Service de médecine intensive et réanimation, Hôpital de la Croix Rousse, Hospices Civils de Lyon, Lyon, France
                [18 ]Department of Intensive Care Medicine, University Hospital, University of Bern, Bern, Switzerland
                [19 ]Department of Intensive Care, Siriraj Hospital, Mahidol University, Bangkok, Thailand
                [20 ]Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia
                Article
                10.1001/jama.2019.22176
                7029761
                31950979
                c5ffd649-bab0-46f1-bfd5-2eac6c9f1c5f
                © 2020
                History

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