Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock - Full Text View

Sponsor:	Rush University Medical Center
Information provided by:	Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT00604019

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 III

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

Drug Information available for: Norepinephrine Dopamine Dopamine hydrochloride Norepinephrine bitartrate

U.S. FDA Resources

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:

Efficacy - dead or alive at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety, arrythmia - yes or no for each group [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment:	251
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	Drug: Dopamine Dopamine 5-20 mcg/kg/min to pre-determined max of 20 Other Name: Dopamine
Active Comparator: Norepinephrine	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):

Patel GP, Grahe JS, Sperry M, Singla S, Elpern E, Lateef O, Balk RA. Efficacy and safety of dopamine versus norepinephrine in the management of septic shock. Shock. 2010 Apr;33(4):375-80.

Responsible Party:	Gourang Patel, PharmD, Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT00604019 History of Changes
Other Study ID Numbers:	ORA-02102801
Study First Received:	January 3, 2008
Last Updated:	April 8, 2011
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 February 12, 2012