Midodrine Hydrochloride in Early Sepsis

Overview

Información sobre este estudio

The investigators would like to determine if early administration of oral Midodrine in participants diagnosed with sepsis will impact blood pressures and decrease the need for and/or doses of intravenous pressor agents.

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

 Patients presenting with sepsis admitted to the ICU and meeting all of the following criteria will be considered eligible to participate in the study:

  • Age greater than or equal to 18 years.
  • Able to tolerate oral medication either by mouth or by feeding tube.
  • Able to give consent for participation or have representative available to give consent.
  • Two or more blood pressure readings taken at least 15 minutes apart with MAPs ≤ 70 OR vasopressor use.
  • Two or more points scored on SOFA.
  • Treating consultant agrees to the study plan.

Exclusion Criteria

Patients meeting any one of the following criteria will be excluded from participation:

  • Women of child bearing age with the potential to become pregnant.
  • Current cardiogenic shock or KNOWN systolic heart failure with LVEF <30%.
  • Current bowel ischemia.
  • Recent Myocardial infarction (STEMI or Type 1 NSTEMI) within the past 3 months, evidence of active coronary ischemia or unstable cardiac rhythm.
  • Current use of Monoamine Oxidase Inhibitors (MAOIs).
  • Recent Stroke (within the past 3 months).
  • High dose vasopressor (norepinephrine more than 0.25 microgram/kg/min).
  • Lactate more than 8 mmol/L.
  • Midodrine use as a home medication.
  • Known allergy to midodrine.
  • Fludrocortisone acetate is a current home medication.
  • Contraindications to use: History of pheochromocytoma or thyrotoxicosis or Acute angle-closure glaucoma or ischemic bowel disease
  • History of peripheral vascular disease requiring intervention - stent or surgery in the past 3 months.

 

 

 

 

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

Rochester, Minn.

Investigador principal de Mayo Clinic

Ognjen Gajic, M.D.

Cerrado para la inscripción

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Pablo Moreno Franco, M.D.

Cerrado para la inscripción

More information

Publicaciones

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CLS-20314309

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