Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients
Condition: Septic Shock; Sepsis; Shock; Tachycardia; Arrhythmia
MeSH terms: Shock, Septic; Arrhythmias, Cardiac; Tachycardia; Shock
Intervention: Phenylephrine; Norepinephrine
Intervention description: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock; Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Septic shock; Vasopressor Agents; Phenylephrine; Norepinephrine; Tachycardia; Heart Rate; Arrhythmia; Catecholamine

Summary:

      Septic shock is a condition that is marked by severe infection causing hypotension requiring
      vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign,
      an international organization formed for the purpose of guiding the management of sepsis and
      septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic
      shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as
      an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate
      cardiac complications. This recommendation is based solely on experience with no scientific
      evidence to support this recommendation.

      The investigators will conduct an open-label randomized controlled trial (RCT) directly
      comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used
      in clinical practice for the management of septic shock. The investigators will perform this
      study with a population of patients that have septic shock to complete the following aims:

      Aim 1: Determine the incidence of tachyarrhythmias.

      Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a
      lower heart rate.

      Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a
      higher incidence of new tachyarrhythmias.

      Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less
      time in tachyarrhythmia.

      Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer
      complications, including cardiac complications.

      The investigators hypothesize that in this setting, phenylephrine will improve the management
      of septic shock when used as a "first choice" vasopressor by:

        1. Decreasing the mean heart rate

        2. Decreasing the incidence of new tachyarrhythmias

        3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new
           onset and recurrent tachyarrhythmias

        4. Decreasing the number of cardiac complications
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18 years of age or greater

          -  Intention to treat with vasopressor for diagnosis of septic shock

          -  Exclusion criteria not met

        Exclusion Criteria:

          -  Emergent indication for surgery

          -  Patient possesses a terminal condition for which patient or medical decision maker has
             decided to de-escalate medical care (patients with Do Not Resuscitate order but for
             whom standard care is continued will not be excluded)

          -  Known allergy to phenylephrine or norepinephrine

          -  Treated with vasopressor >12 hours for current episode of shock

          -  Preference of specific vasopressor agent by patient's provider

          -  Pregnancy