Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock

This study is currently recruiting participants.

Verified by Rush University Medical Center, February 2009

First Received: January 3, 2008 Last Updated: February 5, 2009 History of Changes

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock

Resource links provided by NLM:

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 ]

Estimated Enrollment:	262
Study Start Date:	March 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
DA: Experimental Dopamine	Drug: Dopamine Dopamine 5-20 mcg/kg/min to pre-determined max of 20
NE: Experimental Norepinephrine	Drug: Norepinephrine Norepinephrine 5-20 mcg/min, to a pre-determined max of 20

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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

Contacts

Contact: Gourang Patel, PharmD	312-942-4258	gourang_p_patel@rush.edu
Contact: Robert A Balk, MD	312-942-5000	robert_balk@rush.edu

Locations

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

Sponsors and Collaborators

Rush University Medical Center

Investigators

Study Chair:

Robert A Balk, MD

Rush University Medical Center

More Information

No publications provided

Responsible Party:	Rush University Medical Center ( Gourang Patel, PharmD )
Study ID Numbers:	ORA-02102801
Study First Received:	January 3, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00604019 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Rush University Medical Center:

sepsis
septic shock

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Cardiotonic Agents
Physiological Effects of Drugs
Infection
Adrenergic Agonists
Dopamine
Pathologic Processes
Therapeutic Uses
Vasoconstrictor Agents
Systemic Inflammatory Response Syndrome
Adrenergic alpha-Agonists

Sympathomimetics
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Inflammation
Sepsis
Shock
Autonomic Agents
Norepinephrine
Shock, Septic
Dopamine Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009