Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients
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| ClinicalTrials.gov Identifier: NCT02203630 |
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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
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| 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 |
|---|---|---|
 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 | |
|---|---|---|---|---|
|
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 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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| Number Analyzed | 8 participants | 9 participants | 17 participants | |
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63
(47 to 84)
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58.4
(47 to 73)
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60.4
(47 to 84)
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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%
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7 41.2%
|
|
| Male |
5 62.5%
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5 55.6%
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10 58.8%
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|
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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%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 8 participants | 9 participants | 17 participants |
| 8 | 9 | 17 | ||
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Heart Rate
Mean (Full Range) Unit of measure: Beats/minute |
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| Number Analyzed | 8 participants | 9 participants | 17 participants | |
|
86.3
(60 to 119)
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97.3
(60 to 132)
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92.4
(60 to 132)
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Mean Blood Pressure
Mean (Full Range) Unit of measure: mm/Hg |
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| Number Analyzed | 8 participants | 9 participants | 17 participants | |
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67.4
(51 to 95)
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66.2
(54 to 79)
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66.7
(51 to 95)
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| Name/Title: | Raj Keriwala |
| Organization: | Vanderbilt University Medical Center |
| Phone: | 615-322-3412 |
| 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 |