Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

Vanderbilt University Medical Center

Status and phase: Terminated; Phase 4

Conditions: Arrhythmia; Tachycardia; Shock; Septic Shock; Sepsis

Treatments: Drug: Phenylephrine; Drug: Norepinephrine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02203630

IRB 140141

UL1TR000445-06 (U.S. NIH Grant/Contract)

UL1RR024975-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Phenylephrine

Active Comparator group

Description:

Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock

Treatment:

Drug: Phenylephrine

Norepinephrine

Active Comparator group

Description:

Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock

Treatment:

Drug: Norepinephrine