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Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock

This study has been completed.
Information provided by (Responsible Party):
Gourang P Patel, Rush University Medical Center Identifier:
First received: January 3, 2008
Last updated: February 26, 2013
Last verified: February 2013
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.

Condition Intervention Phase
Septic Shock
Drug: Dopamine
Drug: Norepinephrine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock

Resource links provided by NLM:

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 28 days ]
    Dead at 28 days

Secondary Outcome Measures:
  • Safety, Arrythmia - Yes or no for Each Group [ Time Frame: 28 days ]

Enrollment: 252
Study Start Date: March 2003
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dopamine
Patients that get Dopamine as an infusion for hypotension
Drug: Dopamine
Dopamine 5-20 mcg/kg/min to pre-determined max of 20
Active Comparator: Norepinephrine
Patients that get norepinephrine as an infusion for hypotension
Drug: Norepinephrine
Norepinephrine 5-20 mcg/min, to a pre-determined max of 20

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00604019

United States, Illinois
RUSH University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Study Chair: Robert A Balk, MD Rush University Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gourang P Patel, Sub-PI, Rush University Medical Center Identifier: NCT00604019     History of Changes
Other Study ID Numbers: ORA-02102801
Study First Received: January 3, 2008
Results First Received: July 20, 2011
Last Updated: February 26, 2013

Keywords provided by Rush University Medical Center:
septic shock

Additional relevant MeSH terms:
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Vasoconstrictor Agents
Dopamine Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Cardiotonic Agents
Protective Agents processed this record on May 25, 2017