Background: The LOVIT (Lessening Organ Dysfunction with Vitamin C) trial is a blinded multicenter randomized clinical trial comparing high-dose intravenous vitamin C to placebo in patients admitted to the intensive care unit with proven or suspected infection as the main diagnosis and receiving a vasopressor.
Objective: We aim to describe a prespecified statistical analysis plan (SAP) for the LOVIT trial prior to unblinding and locking of the trial database.
Methods: The SAP was designed by the LOVIT principal investigators and statisticians, and approved by the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes, and describes the planned primary, secondary, and subgroup analyses.
Results: The SAP includes a draft participant flow diagram, tables, and planned figures. The primary outcome is a composite of mortality and persistent organ dysfunction (receipt of mechanical ventilation, vasopressors, or new renal replacement therapy) at 28 days, where day 1 is the day of randomization. All analyses will use a frequentist statistical framework. The analysis of the primary outcome will estimate the risk ratio and 95% CI in a generalized linear mixed model with binomial distribution and log link, with site as a random effect. We will perform a secondary analysis adjusting for prespecified baseline clinical variables. Subgroup analyses will include age, sex, frailty, severity of illness, Sepsis-3 definition of septic shock, baseline ascorbic acid level, and COVID-19 status.
Conclusions: We have developed an SAP for the LOVIT trial and will adhere to it in the analysis phase.
International Registered Report Identifier (irrid): DERR1-10.2196/36261.
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http://dx.doi.org/10.2196/36261 | DOI Listing |
J Pediatr Hematol Oncol
January 2025
Departments of Pediatric Hematology.
Congenital thrombotic thrombocytopenic purpura (cTTP), which is associated with mutations in the gene for a disintegrin and metalloproteinase with a thrombospondin type 1 motif member 13 (ADAMTS13), is a chronic and lifelong disease. The clinical course is variable. Regularly using ADAMTS13-containing products such as fresh frozen plasma (FFP) for long-term prophylaxis is the most important treatment to prevent thrombotic microangiopathy (TMA) episodes.
View Article and Find Full Text PDFOman Med J
July 2024
Department of Medicine, Faculty of Medicine, Royal College of Medicine, Universiti Kuala Lumpur, Perak, Malaysia.
Polyangiitis overlap syndrome (POS) is a systemic vasculitis characterized by overlapping features of more than one well-defined vasculitic syndrome. We present the case of a 38-year-old Malay man with progressive dyspnea and palpable purpura in his lower limbs. The diagnostic evaluation revealed right-sided segmental pulmonary consolidation with pleural effusion, systolic cardiac dysfunction with the presence of an intracardiac thrombus, and left vocal cord palsy secondary to laryngeal mononeuropathy.
View Article and Find Full Text PDFJ Cardiothorac Surg
December 2024
Department of Cardiovascular Surgery, Kanazawa University, Takaramachi 13-1, Kanazawa, 920-8641, Japan.
Background: Acute type A aortic dissection (A-AAD) with severe acute aortic regurgitation (AR) and coronary involvement is a potentially fatal condition that causes left ventricular volume overload and catastrophic acute myocardial infarction. We present the successful management of a patient using Impella 5.5 following cardiopulmonary arrest caused by A-AAD with severe acute AR and left main trunk (LMT) obstruction.
View Article and Find Full Text PDFFront Med (Lausanne)
December 2024
Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, China.
Organ fibrosis is a pathological process characterized by the inability of normal tissue cells to regenerate sufficiently to meet the dynamic repair demands of chronic injury, resulting in excessive extracellular matrix deposition and ultimately leading to organ dysfunction. Despite the increasing depth of research in the field of organ fibrosis and a more comprehensive understanding of its pathogenesis, effective treatments for fibrosis-related diseases are still lacking. Melatonin, a neuroendocrine hormone synthesized by the pineal gland, plays a crucial role in regulating biological rhythms, sleep, and antioxidant defenses.
View Article and Find Full Text PDFFront Med (Lausanne)
December 2024
Department of Cardiology, The University-Town Hospital of Chongqing Medical University, Chongqing, China.
Purpose: To systematically evaluate the clinical efficacy and safety of targeted drugs in patients with pulmonary arterial hypertension (PAH) with cardiac function grades III-IV, and conduct a meta-analysis.
Methods: Two researchers independently searched the PubMed, EMBASE, and Cochrane Library databases for relevant studies, with the search period extending from the establishment of the databases to March 2024. Meta-analysis was performed using statistical software Review Manager 5.
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