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

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.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

DRUG

sodium-selenite

An intravenous bolus of 1000 µg followed by a continuous intravenous infusion of 1000 µg/day until patient is discharged from the ICU but not more than 21 applications à 24 hours.

DRUG

Placebo

An intravenous bolus of placebo followed by a continuous intravenous infusion with placebo until patient is discharged from the ICU but not more than 21 applications à 24 hours.

PROCEDURE

Procalcitonin guided therapy

Causal therapy of sepsis is guided by applying the following algorithm: Day 4: PCT drop from baseline \>=50%: no change in causal therapy; PCT drop from baseline \<50%: change or optimize antimicrobial therapy, new intervention (i.e. surgery, diagnostics) recommended for source control. Day 7, 10, 14: PCT \<=1.0 ng/ml: finish antimicrobial therapy; PCT \>1.0 ng/ml and PCT drop from last PCT measurement \>=50%: finish antimicrobial therapy; PCT \>1.0 ng/ml and PCT drop from last PCT measurement \<50%: change or optimize antimicrobial therapy, new intervention (i.e. surgery, diagnostics) recommended for source control.

Sponsors & Collaborators

• Biosyn

  collaborator INDUSTRY

• Brahms AG

  collaborator INDUSTRY

• Kompetenznetz Sepsis

  lead NETWORK

Principal Investigators

• Konrad Reinhart, M.D. · University Hospital Jena; Dep. of Anesthesiology and Intensive Care Medicine

• Markus Löffler · University Leipzig; Koordinierungszentrum für Klinische Studien Leipzig (KKSL)

• Thomas Deufel, M. D. · University Hopitel Jena, Institute for Medical Chemistry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2013-03-31

Completion

2013-06-30

Countries

• Germany

Study Locations