Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

NCT ID: NCT02203630

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-01-31

Brief 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

Conditions

Septic Shock; Sepsis; Shock; Tachycardia; Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phenylephrine

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

Group Type: ACTIVE_COMPARATOR

Phenylephrine

Intervention Type: DRUG

Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock

Norepinephrine

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

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock

Interventions

Phenylephrine

Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock

Intervention Type: DRUG

Norepinephrine

Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock

Intervention Type: DRUG

Other Intervention Names

Neosynephrine; Levophed

Eligibility Criteria

Inclusion Criteria

• Adults 18 years of age or greater
• Intention to treat with vasopressor for diagnosis of septic shock

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raj Keriwala, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Medicine

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

UL1RR024975-01

Identifier Type: NIH

Identifier Source: secondary_id

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UL1TR000445-06

Identifier Type: NIH

Identifier Source: secondary_id

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IRB 140141

Identifier Type: -

Identifier Source: org_study_id