Status:
COMPLETED
Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis
Lead Sponsor:
Kompetenznetz Sepsis
Collaborating Sponsors:
Biosyn
Brahms AG
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Severe sepsis and septic shock are diseases of infectious origin with a high risk of death. The purpose of this study is to determine whether the intravenous application of selenium (given as sodium-s...
Detailed Description
This is a multicenter trial of the German Network Sepsis (SepNet) on patients with severe sepsis or septic shock. This study is supported by unrestricted grants. The release of reactive oxygen specie...
Eligibility Criteria
Inclusion
- Severe sepsis or septic shock according to ACCP/SCCM criteria
- Onset of severe sepsis or septic shock \<24 h
- Age \>= 18 years
- Informed consent
Exclusion
- Pregnant or breast-feeding women
- Fertile female women without effective contraception
- Participation in interventional clinical trial within the last 30 days
- Current participation in any study
- Former participation in this trial
- Selenium intoxication
- No commitment to full patient support (i.e. DNR order)
- Patient's death is considered imminent due to coexisting disease
- Relationship of the patient to study team member (i.e. colleague, relative)
- Infection where guidelines recommend a longer duration of antimicrobial therapy (i.e. endocarditis, tuberculosis, malaria etc)
- Immunocompromised patients
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
1089 Patients enrolled
Trial Details
Trial ID
NCT00832039
Start Date
November 1 2009
End Date
June 1 2013
Last Update
August 12 2016
Active Locations (35)
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1
University Hospital Aachen - Dep. of Intensive Care Medicine
Aachen, Germany, 52074
2
Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine
Augsburg, Germany, 86156
3
Klinikum Augsburg - Dep. of Medicine I
Augsburg, Germany, 86156
4
Military Hospital Berlin - Dep. of Anaesthesiology and Intensive Care Medicine
Berlin, Germany, 10115