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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Maximum Heart Rate
Time frame: Up to 28 days
Number of Participants With Arrhythmia Events
Time frame: Up to 28 days
Total Time in Arrhythmia
Time frame: Up to 28 days
Number of Patients With ST-segment Abnormalities on ECG
ST Elevation of 1 mm in 2 or more consecutive leads or Horizontal or downsloping ST depression of 1 mm in 2 or more consecutive leads
Time frame: Up to 28 days
Number of Uses of Rate-controlling Agent
includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil
Time frame: Up to 28 days
Number of Times an Anti-arrhythmic Agent is Used
Time frame: Up to 28 days
Use of Corticosteroid
number of days participants received a corticosteroid
Time frame: Up to 28 days
Number of Direct Current (DC) Cardioversion Events
Time frame: Up to 28 days
Number of Days Mechanical Ventilation Needed
Time frame: Up to 28 days
Number of Days Hemodialysis Needed
Time frame: Up to 28 days
Mean Sequential Organ Failure Assessment (SOFA) Score
Predicts ICU mortality based on lab results and clinical data. Range is 0-24 with higher numbers indicating a higher risk of mortality
Time frame: Up to 28 days
Number of Participants Developing Peripheral Limb Ischemia
Time frame: Up to 28 days
Number of Participants With Cardiac Arrest Events
Time frame: Up to 28 days
Number of Days Without Vasopressor Use
Shock free days
Time frame: Up to 28 days
Number of Days Without Mechanical Ventilation
Mechanical ventilation-free days
Time frame: Up to 28 days
Days Without Dialysis
Dialysis-free days
Time frame: Up to 28 days
Hospital Days Not in ICU
ICU free days
Time frame: Up to 28 days
Days Spent Out of the Hospital
Hospital free days
Time frame: Up to 28 days
Readmission to ICU
Time frame: Up to 28 days
Number of Participants Rehospitalized After Discharge
Time frame: Up to 28 days
Length of ICU Stay
Time frame: Up to 28 days
Length of Hospital Stay
Time frame: Up to 28 days
28-day Mortality
Time frame: Up to 28 days
Location of Death
Time frame: Up to 28 days
Cause of Death
Time frame: Up to 28 days
Mean Troponin-I
From chart review (if available)
Time frame: Up to 28 days
CK-MB
From chart review (if available)
Time frame: Up to 28 days
Creatinine Kinase (CK)
From chart review (if available)
Time frame: Up to 28 days
Number of Participants Receiving Non-study Vasopressors
Time frame: Up to 28 days
Amount of Time Non-study Vasopressors Used
Time frame: Up to 28 days
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