Trial Outcomes & Findings for Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients (NCT NCT02203630)

NCT ID: NCT02203630

Last Updated: 2018-06-13

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: Up to 28 days
• Results posted on: 2018-06-13

Participant Flow

Participant milestones

Measure	Phenylephrine 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 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 Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

Baseline characteristics by cohort

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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 n=17 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Heart Rate	86.3 beats/minute n=5 Participants	97.3 beats/minute n=7 Participants	92.4 beats/minute n=5 Participants
Age, Continuous	63 years n=5 Participants	58.4 years n=7 Participants	60.4 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Mean Blood Pressure	67.4 mm/Hg n=5 Participants	66.2 mm/Hg n=7 Participants	66.7 mm/Hg n=5 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Maximum Heart Rate	96.7 beats/minute Interval 65.0 to 132.0	108.6 beats/minute Interval 57.0 to 153.0

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Participants With Arrhythmia Events	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: only participants with arrhythmias included

Outcome measures

Measure	Phenylephrine n=1 Participants 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 n=2 Participants 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 Time in Arrhythmia atrial fibrillation	1224 minutes	209 minutes
Total Time in Arrhythmia Other (undetermined) arrthymia	0 minutes	2332 minutes

SECONDARY outcome

Timeframe: Up to 28 days

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

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Patients With ST-segment Abnormalities on ECG	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Uses of Rate-controlling Agent	0 number of uses	0 number of uses

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Times an Anti-arrhythmic Agent is Used	2 events	1 events

SECONDARY outcome

Timeframe: Up to 28 days

number of days participants received a corticosteroid

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Use of Corticosteroid	1 days	10 days

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Direct Current (DC) Cardioversion Events	0 DC cardioversion events	0 DC cardioversion events

SECONDARY outcome

Timeframe: Up to 28 days

Population: only participants that required mechanical ventilation

Outcome measures

Measure	Phenylephrine n=2 Participants 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 n=6 Participants 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
Number of Days Mechanical Ventilation Needed	3 days	22 days

SECONDARY outcome

Timeframe: Up to 28 days

Population: only participants that required dialysis

Outcome measures

Measure	Phenylephrine n=1 Participants 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 n=2 Participants 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
Number of Days Hemodialysis Needed	1 days	11 days

SECONDARY outcome

Timeframe: Up to 28 days

Population: data was not collected

Predicts ICU mortality based on lab results and clinical data. Range is 0-24 with higher numbers indicating a higher risk of mortality

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Participants Developing Peripheral Limb Ischemia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Participants With Cardiac Arrest Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Shock free days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Days Without Vasopressor Use	154 days	151 days

SECONDARY outcome

Timeframe: Up to 28 days

Mechanical ventilation-free days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Days Without Mechanical Ventilation	165 days	164 days

SECONDARY outcome

Timeframe: Up to 28 days

Dialysis-free days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Days Without Dialysis	168 days	152 days

SECONDARY outcome

Timeframe: Up to 28 days

ICU free days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Hospital Days Not in ICU	144 days	139 days

SECONDARY outcome

Timeframe: Up to 28 days

Hospital free days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Days Spent Out of the Hospital	103 days	98 days

SECONDARY outcome

Timeframe: Up to 28 days

Population: data was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Participants Rehospitalized After Discharge	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Length of ICU Stay	4.1 days Interval 2.0 to 6.0	5.2 days Interval 2.0 to 17.0

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Length of Hospital Stay	10 days Interval 4.0 to 26.0	8.9 days Interval 3.0 to 28.0

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
28-day Mortality	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=1 Participants 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 n=4 Participants 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
Location of Death ICU	0 Participants	4 Participants
Location of Death Not recorded	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=2 Participants 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 n=3 Participants 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
Cause of Death E. coli bacteremia, aspiration pnemonia	0 Participants	1 Participants
Cause of Death Respiratory failure,hospital aquired pneumonia	1 Participants	0 Participants
Cause of Death septic shock	1 Participants	1 Participants
Cause of Death Hypoxemic respiratory failure	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: patients with troponin levels

From chart review (if available)

Outcome measures

Measure	Phenylephrine n=1 Participants 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 n=2 Participants 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
Mean Troponin-I	0.22 ng/mL Interval 0.22 to 0.22	0.38 ng/mL Interval 0.1 to 0.6

SECONDARY outcome

Timeframe: Up to 28 days

Population: patients with CK-MB levels

From chart review (if available)

Outcome measures

Measure	Phenylephrine n=1 Participants 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 n=1 Participants 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
CK-MB	8.87 ng/mL Interval 8.87 to 8.87	5.07 ng/mL Interval 5.07 to 5.07

SECONDARY outcome

Timeframe: Up to 28 days

Population: patients with CK levels

From chart review (if available)

Outcome measures

Measure	Phenylephrine n=1 Participants 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 n=2 Participants 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
Creatinine Kinase (CK)	738 units/L Interval 738.0 to 738.0	6986.6 units/L Interval 242.0 to 13211.0

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Number of Participants Receiving Non-study Vasopressors	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: participants receiving non-study vasopressors

Outcome measures

Measure	Phenylephrine n=3 Participants 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 n=3 Participants 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
Amount of Time Non-study Vasopressors Used Epinephrine	0 hours	16 hours
Amount of Time Non-study Vasopressors Used Phenylephrine	0 hours	13 hours
Amount of Time Non-study Vasopressors Used Norepinephrine	0 hours	0 hours
Amount of Time Non-study Vasopressors Used Vasopressin	8 hours	22 hours

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Mean Blood Pressure (Maximum and Minimum) minimum	55.8 mm/Hg Interval 40.0 to 63.0	53.8 mm/Hg Interval 42.0 to 65.0
Mean Blood Pressure (Maximum and Minimum) maximum	88.6 mm/Hg Interval 77.0 to 109.0	79.5 mm/Hg Interval 71.0 to 92.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days

Outcome measures

Measure	Phenylephrine n=8 Participants 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 n=9 Participants 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
Mean Central Venous Pressure	10.4 mm/Hg Interval 7.0 to 14.0	11.7 mm/Hg Interval 7.0 to 17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days

From chart review (if available)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days

Population: patients with central venous pressure readings

From chart review (if available)

Outcome measures

Measure	Phenylephrine n=3 Participants 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 n=4 Participants 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
Mean Central Venous Oxygen Saturation	10.4 mm/Hg Interval 7.0 to 14.0	11.7 mm/Hg Interval 7.0 to 17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days

Outcome measures

Outcome data not reported

Adverse Events

Phenylephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Norepinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raj Keriwala

Vanderbilt University Medical Center

Phone: 615-322-3412

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place