Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02203630
• Other study ID #: IRB 140141
• Secondary ID: UL1RR024975-01UL
• Status: Terminated
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Critical Illness
• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Tachycardia

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Center for Advancing Translational Science (NCATS), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Blood Pressure (Maximum and Minimum)		Up to 28 days
Other	Mean Central Venous Pressure		Up to 28 days
Other	Mean Metabolic Panel Laboratory Values	From chart review (if available)	Up to 28 days
Other	Mean Central Venous Oxygen Saturation	From chart review (if available)	Up to 28 days
Other	Anti-hypertensive Agents Used		Up to 28 days
Other	Diuretic Agents Used		Up to 28 days
Other	Inotropes Used		Up to 28 days
Primary	Maximum Heart Rate		Up to 28 days
Secondary	Number of Participants With Arrhythmia Events		Up to 28 days
Secondary	Total Time in Arrhythmia		Up to 28 days
Secondary	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	Up to 28 days
Secondary	Number of Uses of Rate-controlling Agent	includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil	Up to 28 days
Secondary	Number of Times an Anti-arrhythmic Agent is Used		Up to 28 days
Secondary	Use of Corticosteroid	number of days participants received a corticosteroid	Up to 28 days
Secondary	Number of Direct Current (DC) Cardioversion Events		Up to 28 days
Secondary	Number of Days Mechanical Ventilation Needed		Up to 28 days
Secondary	Number of Days Hemodialysis Needed		Up to 28 days
Secondary	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	Up to 28 days
Secondary	Number of Participants Developing Peripheral Limb Ischemia		Up to 28 days
Secondary	Number of Participants With Cardiac Arrest Events		Up to 28 days
Secondary	Number of Days Without Vasopressor Use	Shock free days	Up to 28 days
Secondary	Number of Days Without Mechanical Ventilation	Mechanical ventilation-free days	Up to 28 days
Secondary	Days Without Dialysis	Dialysis-free days	Up to 28 days
Secondary	Hospital Days Not in ICU	ICU free days	Up to 28 days
Secondary	Days Spent Out of the Hospital	Hospital free days	Up to 28 days
Secondary	Readmission to ICU		Up to 28 days
Secondary	Number of Participants Rehospitalized After Discharge		Up to 28 days
Secondary	Length of ICU Stay		Up to 28 days
Secondary	Length of Hospital Stay		Up to 28 days
Secondary	28-day Mortality		Up to 28 days
Secondary	Location of Death		Up to 28 days
Secondary	Cause of Death		Up to 28 days
Secondary	Mean Troponin-I	From chart review (if available)	Up to 28 days
Secondary	CK-MB	From chart review (if available)	Up to 28 days
Secondary	Creatinine Kinase (CK)	From chart review (if available)	Up to 28 days
Secondary	Number of Participants Receiving Non-study Vasopressors		Up to 28 days
Secondary	Amount of Time Non-study Vasopressors Used		Up to 28 days