Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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-selenite) can reduce mortality in patients with severe sepsis or septic shock. Additionally, it is investigated, whether the measurement of procalcitonin - a marker of infection - can be used to guide anti-infectious measures in this disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kompetenznetz Sepsis
• Collaborators: Biosyn; Brahms AG
• Treatments: Anti-Infective Agents; Selenious Acid; Sodium Selenite

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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