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A Pilot Trial of Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock; Sepsis; Shock; Tachycardia; Arrhythmia

Intervention: Phenylephrine (Drug); Norepinephrine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Raj Keriwala, MD, MPH, Principal Investigator, Affiliation: Vanderbilt University School of Medicine

Overall contact:
Raj Keriwala, MD, MPH, Phone: 615-322-3412

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

Clinical Details

Official title: A Randomized Controlled Pilot Trial of Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean maximum heart rate

Secondary outcome:

Number of arrhythmia events

Total time in arrhythmia

ST-segment abnormalities on ECG

Use of rate-controlling agent

Use of anti-arrhythmic agent

Use of corticosteroid

Number of direct current (DC) cardioversion events

Number of days mechanical ventilation needed

Number of days hemodialysis needed

Mean Sequential Organ Failure Assessment score

Occurrence of peripheral limb ischemia

Number of cardiac arrest events

Shock-free days

Mechanical ventilation-free days

Dialysis-free days

ICU-free days

Hospital-free days

Readmission to ICU

Rehospitalization

Length of ICU stay

Length of hospital stay

28-day Mortality

Location of death

Cause of death

Mean troponin-I

CK-MB

Creatinine kinase (CK)

Non-study vasopressors used

Amount of time non-study vasopressors used

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Raj Keriwala, MD, MPH, Phone: 615-322-3412

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Additional Information

Starting date: August 2014
Last updated: August 13, 2014

Page last updated: August 23, 2015

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