Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock

NCT00604019 | Completed Phase 3 Results DMC

• 1 other identifier: ORA-02102801
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

sepsis; septic shock

Outcome Measures

Primary Outcomes (1)

• Efficacy and Safety of Dopamine Versus Norepinephrine in Septic Shock

  We measured 28 day all-cause mortality in randomized patients with septic shock managed with a vasopressor protocol containing either dopamine versus norepinephrine.

  28 days

Secondary Outcomes (1)

• Safety, Arrythmia - Yes or no for Each Group

  28 days

Study Arms (2)

Dopamine

ACTIVE COMPARATOR

Patients that get Dopamine as an infusion for hypotension

Drug: Dopamine

Norepinephrine

ACTIVE COMPARATOR

Patients that get norepinephrine as an infusion for hypotension

Drug: Norepinephrine

Interventions

Dopamine DRUG

Dopamine 5-20 mcg/kg/min to pre-determined max of 20

Dopamine

Norepinephrine DRUG

Norepinephrine 5-20 mcg/min, to a pre-determined max of 20

Norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

RUSH University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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. doi: 10.1097/SHK.0b013e3181c6ba6f.

  PMID: 19851126 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Dopamine; Norepinephrine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ethanolamines; Amino Alcohols; Alcohols

Results Point of Contact

• Title: Gourang Patel, PharmD
• Organization: RUSH University Medical Center

gourang_p_patel@rush.edu

312-942-4258

Study Officials

• Robert A Balk, MD

  Rush University Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 29, 2008
• Study Start: March 1, 2003
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 11, 2023
• Results First Posted: December 7, 2012

Record last verified: 2022-12

Locations

US (1)