CompletedPhase 3

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

Germany1,089 participantsStarted 2009-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

All cause mortality

Timeframe: 28 days

Trial details

NCT IDNCT00832039

SponsorKompetenznetz Sepsis

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2013-03

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