Phase 3
N=252
Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock
Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT00604019 ↗Enrolled (actual)
252
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Efficacy and Safety of Dopamine Versus Norepinephrine in Septic Shock — 67; 51 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dopamine (Drug); Norepinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy and Safety of Dopamine Versus Norepinephrine in Septic Shock |
67; 51 | — |
| SECONDARY Safety, Arrythmia - Yes or no for Each Group |
51; 14; 83; 104 | — |
Summary
We are performing a prospective, randomized, controlled trial of dopamine versus norepinephrine for septic shock. The trial will enroll patients with suspected or documented site of infection and having 2 out of the three SIRS criteria. Patients will also be receiving standard of care, early-goal directed therapy including but not limited to fluid resuscitation, appropriate and early antibiotics, source control and evaluation for drotrecogin alpha where deemed appropriate, while being supported for septic shock.
Eligibility Criteria
Inclusion Criteria
- Patients are transferred to our medical intensive care unit from the emergency room (ER), general medical floors, and from outside hospitals.
- Patients were eligible if they were greater than 18 years of age
- Presented with a diagnosis of SIRS plus a suspected or documented source of infection.
Exclusion Criteria
- Patients were not eligible if they were found to have hypovolemic and/or hemorrhagic etiologies of their vasodilatory shock or another etiology of their SIRS.
Data sourced from ClinicalTrials.gov (NCT00604019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.