Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203630
Recruitment Status : Terminated (Slow enrollment; Lack of support and equipoise)
First Posted : July 30, 2014
Results First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Septic Shock
Sepsis
Shock
Tachycardia
Arrhythmia
Interventions Drug: Phenylephrine
Drug: Norepinephrine
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description

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

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

Norepinephrine 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

Period Title: Overall Study
Started 8 9
Completed 8 9
Not Completed 0 0
Arm/Group Title Phenylephrine Norepinephrine Total
Hide Arm/Group Description

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

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

Norepinephrine 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

Total of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 17 participants
63
(47 to 84)
58.4
(47 to 73)
60.4
(47 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
3
  37.5%
4
  44.4%
7
  41.2%
Male
5
  62.5%
5
  55.6%
10
  58.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  11.1%
1
   5.9%
White
8
 100.0%
8
  88.9%
16
  94.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 9 participants 17 participants
8 9 17
Heart Rate  
Mean (Full Range)
Unit of measure:  Beats/minute
Number Analyzed 8 participants 9 participants 17 participants
86.3
(60 to 119)
97.3
(60 to 132)
92.4
(60 to 132)
Mean Blood Pressure  
Mean (Full Range)
Unit of measure:  mm/Hg
Number Analyzed 8 participants 9 participants 17 participants
67.4
(51 to 95)
66.2
(54 to 79)
66.7
(51 to 95)
1.Primary Outcome
Title Maximum Heart Rate
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Mean (Full Range)
Unit of Measure: beats/minute
96.7
(65 to 132)
108.6
(57 to 153)
2.Secondary Outcome
Title Number of Participants With Arrhythmia Events
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
1
  12.5%
2
  22.2%
3.Secondary Outcome
Title Total Time in Arrhythmia
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
only participants with arrhythmias included
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 1 2
Measure Type: Number
Unit of Measure: minutes
atrial fibrillation 1224 209
Other (undetermined) arrthymia 0 2332
4.Secondary Outcome
Title Number of Patients With ST-segment Abnormalities on ECG
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Uses of Rate-controlling Agent
Hide Description includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: number of uses
0 0
6.Secondary Outcome
Title Number of Times an Anti-arrhythmic Agent is Used
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: events
2 1
7.Secondary Outcome
Title Use of Corticosteroid
Hide Description number of days participants received a corticosteroid
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: days
1 10
8.Secondary Outcome
Title Number of Direct Current (DC) Cardioversion Events
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: DC cardioversion events
0 0
9.Secondary Outcome
Title Number of Days Mechanical Ventilation Needed
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
only participants that required mechanical ventilation
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 2 6
Measure Type: Number
Unit of Measure: days
3 22
10.Secondary Outcome
Title Number of Days Hemodialysis Needed
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
only participants that required dialysis
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 1 2
Measure Type: Number
Unit of Measure: days
1 11
11.Secondary Outcome
Title Mean Sequential Organ Failure Assessment (SOFA) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
data was not collected
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of Participants Developing Peripheral Limb Ischemia
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Cardiac Arrest Events
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Days Without Vasopressor Use
Hide Description Shock free days
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: days
154 151
15.Secondary Outcome
Title Number of Days Without Mechanical Ventilation
Hide Description Mechanical ventilation-free days
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: days
165 164
16.Secondary Outcome
Title Days Without Dialysis
Hide Description Dialysis-free days
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: days
168 152
17.Secondary Outcome
Title Hospital Days Not in ICU
Hide Description ICU free days
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: days
144 139
18.Secondary Outcome
Title Days Spent Out of the Hospital
Hide Description Hospital free days
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: days
103 98
19.Secondary Outcome
Title Readmission to ICU
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
data was not collected
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Number of Participants Rehospitalized After Discharge
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Length of ICU Stay
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Mean (Full Range)
Unit of Measure: days
4.1
(2 to 6)
5.2
(2 to 17)
22.Secondary Outcome
Title Length of Hospital Stay
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Mean (Full Range)
Unit of Measure: days
10
(4 to 26)
8.9
(3 to 28)
23.Secondary Outcome
Title 28-day Mortality
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
3
  33.3%
24.Secondary Outcome
Title Location of Death
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 1 4
Measure Type: Count of Participants
Unit of Measure: Participants
ICU
0
   0.0%
4
 100.0%
Not recorded
1
 100.0%
0
   0.0%
25.Secondary Outcome
Title Cause of Death
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 2 3
Measure Type: Count of Participants
Unit of Measure: Participants
E. coli bacteremia, aspiration pnemonia
0
   0.0%
1
  33.3%
Respiratory failure,hospital aquired pneumonia
1
  50.0%
0
   0.0%
septic shock
1
  50.0%
1
  33.3%
Hypoxemic respiratory failure
0
   0.0%
1
  33.3%
26.Secondary Outcome
Title Mean Troponin-I
Hide Description From chart review (if available)
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients with troponin levels
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 1 2
Mean (Full Range)
Unit of Measure: ng/mL
0.22
(0.22 to 0.22)
0.38
(0.1 to 0.6)
27.Secondary Outcome
Title CK-MB
Hide Description From chart review (if available)
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients with CK-MB levels
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 1 1
Mean (Full Range)
Unit of Measure: ng/mL
8.87
(8.87 to 8.87)
5.07
(5.07 to 5.07)
28.Secondary Outcome
Title Creatinine Kinase (CK)
Hide Description From chart review (if available)
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients with CK levels
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 1 2
Mean (Full Range)
Unit of Measure: units/L
738
(738 to 738)
6986.6
(242 to 13211)
29.Secondary Outcome
Title Number of Participants Receiving Non-study Vasopressors
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
3
  37.5%
3
  33.3%
30.Secondary Outcome
Title Amount of Time Non-study Vasopressors Used
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
participants receiving non-study vasopressors
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: hours
Phenylephrine 0 13
Norepinephrine 0 0
Vasopressin 8 22
Epinephrine 0 16
31.Other Pre-specified Outcome
Title Mean Blood Pressure (Maximum and Minimum)
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Mean (Full Range)
Unit of Measure: mm/Hg
minimum
55.8
(40 to 63)
53.8
(42 to 65)
maximum
88.6
(77 to 109)
79.5
(71 to 92)
32.Other Pre-specified Outcome
Title Mean Central Venous Pressure
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 8 9
Mean (Full Range)
Unit of Measure: mm/Hg
10.4
(7 to 14)
11.7
(7 to 17)
33.Other Pre-specified Outcome
Title Mean Metabolic Panel Laboratory Values
Hide Description From chart review (if available)
Time Frame Up to 28 days
Outcome Measure Data Not Reported
34.Other Pre-specified Outcome
Title Mean Central Venous Oxygen Saturation
Hide Description From chart review (if available)
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients with central venous pressure readings
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description:

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

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

Norepinephrine 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

Overall Number of Participants Analyzed 3 4
Mean (Full Range)
Unit of Measure: mm/Hg
10.4
(7 to 14)
11.7
(7 to 17)
35.Other Pre-specified Outcome
Title Anti-hypertensive Agents Used
Hide Description [Not Specified]
Time Frame Up to 28 days
Outcome Measure Data Not Reported
36.Other Pre-specified Outcome
Title Diuretic Agents Used
Hide Description [Not Specified]
Time Frame Up to 28 days
Outcome Measure Data Not Reported
37.Other Pre-specified Outcome
Title Inotropes Used
Hide Description [Not Specified]
Time Frame Up to 28 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events and Serious adverse events will not include organ failure or death that is related to septic shock, which are expected complications in this population, unless they are more severe than is expected or unusual in their happenstances.
 
Arm/Group Title Phenylephrine Norepinephrine
Hide Arm/Group Description

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

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

Norepinephrine 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

All-Cause Mortality
Phenylephrine Norepinephrine
Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   3/9 (33.33%) 
Hide Serious Adverse Events
Phenylephrine Norepinephrine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phenylephrine Norepinephrine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Study was terminated early due to slow enrollment, lack of support and equipoise. PI left Vanderbilt and the record was completed with data recorded in REDCap.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Raj Keriwala
Organization: Vanderbilt University Medical Center
Phone: 615-322-3412
Layout table for additonal information
Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02203630    
Other Study ID Numbers: IRB 140141
UL1RR024975-01 ( U.S. NIH Grant/Contract )
UL1TR000445-06 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2014
First Posted: July 30, 2014
Results First Submitted: April 4, 2018
Results First Posted: June 13, 2018
Last Update Posted: June 13, 2018