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Study to Determine Safety and Effectiveness of Ascorbic Acid, Corticosteroids, and Thiamine in Treating Sepsis and Septic Shock

Overview

Información sobre este estudio

The purpose of this study is to determine whether the combination of Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and Corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Adult participant (age ≥ 18 years old).
  • Suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection.
  • Receiving (continous infusion) vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin II or vasopressin):
    • Hypotension related primarily to sepsis as opposed to another cause of hypotension (e.g., bleed, cardiogenic shock).

Exclusion Criteria: 

  • Member of a protected population (pregnant, prisoner).
  • Known history of kidney stones within the past 1 year (not including incidentally noted stones noted on imaging studies).
  • End stage renal disease requiring dialysis (hemodialysis or peritoneal dialysis).
  • Known history of G6PD deficiency.
  • Known history of Hemochromatosis.
  • Comfort Measures Only status.
  • Anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician).
  • Receiving supplemental vitamin 81 in a dose greater than that contained in a multivitamin (< 2mg).
  • Clinical indication for steroids (e.g., chronic use) as determined by the clinical team providing this drug.
  • Clinical indication for ascorbic acid supplementation in any form.
  • Clinical indication for vitamin 81 as determined by the clinical team providing this drug.
  • Known allergy to vitamin C, hydrocortisone, or vitamin 81.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Ayan Sen, M.D.

Cerrado para la inscripción

More information

Publicaciones

  • The global burden of sepsis is estimated as 15 to 19 million cases annually, with a mortality rate approaching 60% in low-income countries. Read More on PubMed
  • Acute kidney injury (AKI) is common in patients with sepsis and has been associated with high mortality rates. The provision of thiamine to patients with sepsis may reduce the incidence and severity of sepsis-related AKI and thereby prevent renal failure requiring renal replacement therapy (RRT). Read More on PubMed
  • To determine if intravenous thiamine would reduce lactate in patients with septic shock. Read More on PubMed

Otros temas en investigación

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CLS-20445273

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