Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients
Status:
Terminated
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
Vanderbilt University Vanderbilt University Medical Center
Collaborators:
National Center for Advancing Translational Science (NCATS) National Center for Research Resources (NCRR)