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Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gourang P Patel, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00604019
First received: January 3, 2008
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Septic Shock
Interventions: Drug: Dopamine
Drug: Norepinephrine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of enrollment were from July 2005 thru July 2008 at RUSH University Medical Center in the Medical Intensive Care Unit

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Dopamine Dopaime infusion via central catheter
Norepinephrine Norepinephrine infusion via central catheter

Participant Flow:   Overall Study
    Dopamine     Norepinephrine  
STARTED     134     118  
COMPLETED     134     118  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Dopamine Patients that get DA infusion
Norepinephrine Patients that get NE infusion
Total Total of all reporting groups

Baseline Measures
    Dopamine     Norepinephrine     Total  
Number of Participants  
[units: participants]
 		  134     118     252  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     100     100     200  
>=65 years     34     18     52  
Age  
[units: years]
Mean ± Standard Deviation 		  56  ± 18     60  ± 15     57  ± 20  
Gender  
[units: participants]
 		     
Female     70     52     122  
Male     64     66     130  
Region of Enrollment  
[units: participants]
 		     
United States     134     118     252  



  Outcome Measures

1.  Primary:   Efficacy   [ Time Frame: 28 days ]
  Show Outcome Measure 1

2.  Secondary:   Safety, Arrythmia - Yes or no for Each Group   [ Time Frame: 28 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gourang Patel, PharmD
Organization: RUSH University Medical Center
phone: 312-942-4258
e-mail: gourang_p_patel@rush.edu


No publications provided by Rush University Medical Center

Publications automatically indexed to this study:


Responsible Party: Gourang P Patel, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00604019     History of Changes
Other Study ID Numbers: ORA-02102801
Study First Received: January 3, 2008
Results First Received: July 20, 2011
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board