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Sponsored by: |
Rush University Medical Center |
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Information provided by: | Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT00604019 |
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 |
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Septic Shock |
Drug: Dopamine Drug: Norepinephrine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock |
Estimated Enrollment: | 262 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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DA: Experimental
Dopamine
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Drug: Dopamine
Dopamine 5-20 mcg/kg/min to pre-determined max of 20
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NE: Experimental
Norepinephrine
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Drug: Norepinephrine
Norepinephrine 5-20 mcg/min, to a pre-determined max of 20
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gourang Patel, PharmD | 312-942-4258 | gourang_p_patel@rush.edu |
Contact: Robert A Balk, MD | 312-942-5000 | robert_balk@rush.edu |
United States, Illinois | |
RUSH University Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Gourang Patel, PharmD 312-942-4258 | |
Principal Investigator: Robert A Balk, MD | |
Sub-Investigator: Gourang Patel, PharmD |
Study Chair: | Robert A Balk, MD | Rush University Medical Center |
Responsible Party: | Rush University Medical Center ( Gourang Patel, PharmD ) |
Study ID Numbers: | ORA-02102801 |
Study First Received: | January 3, 2008 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00604019 |
Health Authority: | United States: Institutional Review Board |
sepsis septic shock |
Systemic Inflammatory Response Syndrome Sepsis Dopamine Shock |
Norepinephrine Shock, Septic Inflammation |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Sympathomimetics Physiological Effects of Drugs Cardiovascular Agents Infection |
Protective Agents Adrenergic Agonists Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents |