|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 January 2013 |
|
Main ID: |
NCT00604019 |
|
Date of registration:
|
03/01/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock
|
|
Scientific title:
|
Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock |
|
Date of first enrolment:
|
March 2003 |
|
Target sample size:
|
251 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00604019 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Robert A Balk, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rush University Medical Center |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Septic Shock
|
|
Intervention(s)
|
|
Drug: Dopamine
|
|
Drug: Norepinephrine
|
|
Primary Outcome(s)
|
|
Efficacy
[Time Frame: 28 days]
|
|
Secondary Outcome(s)
|
|
Safety, Arrythmia - Yes or no for Each Group
[Time Frame: 28 days]
|
|
Secondary ID(s)
|
|
ORA-02102801
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|