Clinical Trial: Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock
Brief 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.
Detailed Summary:
Research Question/Hypothesis: The initial selection of the vasopressor norepinephrine in comparison to dopamine will result in a decrease in mortality for patients in septic shock.
Study Design/Source Population:
This trial is a single-center, prospective, randomized, open-label comparison of dopamine versus norepinephrine as initial vasopressor for patients presenting with septic shock. The study takes place at Rush University Medical Center, a 600 bed facility. 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, and presented with a diagnosis of SIRS plus a suspected or documented source of infection. 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.
Patients in the medical intensive care unit presenting with septic shock were randomized to receive either dopamine or norepinephrine as the first-line vasopressors for septic shock. Randomization was based upon whether the patient presented on an odd or even day of the week. For example, if the patient had presented on the third then they would be randomized to dopamine and if they had presented to the ICU on the fourth then they would be randomized to the norepinephrine treatment arm. The study investigators accept that the randomization scheme is not truly randomized, however a patient presenting with sepsis is not dependent on the day of the week. For example, the timeline for a patient to present with sepsis is unpredictable and the therapy for septic shock is started immediately upon their diagnosis, therefore the selection of a vasoactive agent (norepinephrin
Sponsor: Rush University Medical Center
Current Primary Outcome: Efficacy [ Time Frame: 28 days ]
Original Primary Outcome: Efficacy - dead or alive at 28 days [ Time Frame: 28 days ]
Current Secondary Outcome: Safety, Arrythmia - Yes or no for Each Group [ Time Frame: 28 days ]
Original Secondary Outcome: Same as current
Information By: Rush University Medical Center
Dates:
Date Received: January 3, 2008
Date Started: March 2003
Date Completion:
Last Updated: February 26, 2013
Last Verified: February 2013
