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Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00604019
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : December 7, 2012
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
Gourang P Patel, Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Dopamine Drug: Norepinephrine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock
Study Start Date : March 2003
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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




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


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


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604019


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gourang P Patel, Sub-PI, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00604019    
Other Study ID Numbers: ORA-02102801
First Posted: January 29, 2008    Key Record Dates
Results First Posted: December 7, 2012
Last Update Posted: March 4, 2013
Last Verified: February 2013
Keywords provided by Gourang P Patel, Rush University Medical Center:
sepsis
septic shock
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Dopamine
Norepinephrine
Vasoconstrictor Agents
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents