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Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gourang P Patel, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00604019
First received: January 3, 2008
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
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:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Dead at 28 days


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

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
Other Name: Dopamine
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
Other Name: Norepinephrine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604019

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

No publications provided by Rush University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gourang P Patel, Sub-PI, Rush University Medical Center
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
sepsis
septic shock

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Dopamine
Norepinephrine
Dopamine Agents
Vasoconstrictor Agents
Cardiotonic Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on May 21, 2013