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NCT02203630 · ClinicalTrials.gov registry record · Phase 4
Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT02203630: Clinical Trial Phase 4 study, sponsored by Vanderbilt University Medical Center.
NCT02203630 is a Phase 4 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02203630, a Phase 4 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study 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 numb
Interventions
- DRUG Norepinephrine
- DRUG Phenylephrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-01 |
| Phase | Phase 4 |
Why NCT02203630 stopped before completion
NCT02203630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Norepinephrine is the first listed.
NCT02203630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02203630 about?
NCT02203630 is a clinical study titled "Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients". 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, currentl...
What is the current status of trial NCT02203630?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2014-08. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02203630?
The interventions under investigation include: Norepinephrine (DRUG), Phenylephrine (DRUG).
Who is sponsoring clinical trial NCT02203630?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02203630's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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