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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,089

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

March 31, 2013

Study Completion Date

June 30, 2013

Conditions
Severe SepsisSeptic 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."

Trial Locations (35)

10115

Military Hospital Berlin - Dep. of Anaesthesiology and Intensive Care Medicine, Berlin

10117

Charité Berlin - Dep. of Anesthesiology and Intensive Care Medicine, Berlin

12313

Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy, Berlin

12559

DRK-Kliniken Berlin-Köpenick - Dep. of Anesthesiology, Pain Therapy, and Intensive Care Medicine, Berlin

13353

Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology, Berlin

17475

Ernst-Moritz-Arndt-Universität Greifswald - Dep. of Anesthesiology and Intensive Care Medicine, Greifswald

20246

Universitätsklinikum Hamburg-Eppendorf - Dep. of Intensive Care Medicine, Hamburg

24105

University Hospital Kiel - Dep. of. Anesthesiology and Intensive Care Medicine, Kiel

25746

Westküstenklinikum Heide - Dep. of Anesthesiology and Intensive Care Medicine, Heide

26133

Klinikum Oldenburg GmbH - Dep. of Anesthesiology, Oldenburg

33617

Ev. Krankenhaus Gilead - Dep. of Anesthesiology, Bielefeld

37075

Georg August Universität Göttingen - Dep. of Anesthesiology and Intensive Care Medicine, Göttingen

48149

University Hospital Münster - Dep. of Anesthesiology and Intensive Care Medicine, Münster

50924

University Hospital Köln - Dep. of Medicine I, Cologne

50935

St. Elisabeth-Krankenhaus - Dep. of Anesthesiology, Köln-Hohenlind

52074

University Hospital Aachen - Dep. of Intensive Care Medicine, Aachen

53105

University Hospital Bonn - Dep. of Anesthesiology and Intensive Care Medicine, Bonn

60590

J.-W. Goethe University Hospital - Dep. of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Frankfurt am Main

68167

University Hospital Mannheim - Dep. of Medicine I, Mannheim

69120

University Hospital Heidelberg - study center Anesthesiology/Surgery, Heidelberg

79106

University Hospital Freiburg- Dep. of Surgery, Freiburg im Breisgau

80336

University Hospital Munich - Dep. of Internal Medicine, Munich

81377

University Hospital Munich - Dep. of Anaesthesiology, Munich

81545

Hospital Munich Harlaching - Dep. of Internal Acute Medicine and Prevention, Munich

81737

Krankenhaus München-Neuperlach - Dep. of Anesthesiology, München

86156

Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine, Augsburg

Klinikum Augsburg - Dep. of Medicine I, Augsburg

91054

University Erlangen-Nürnberg - Dep. of Medicine IV, Erlangen

99089

HELIOS Klinikum Erfurt - Dep. of Anesthesiology and Intensive Care Medicine, Erfurt

01067

Krankenhaus Dresden-Friedrichstadt, Dresden

01307

University Hospital Dresden - Dep. of Anesthesiology and Intensive Care Med., Dresden

06097

Martin-Luther-Universität Halle-Wittenberg - Dep. of Anesthesiology, Halle

06120

University Hospital Halle - Dep. of Medicine III, Halle

07747

University Hospital Jena, Dep. of Anesthesiology and Intensive Care Medicine, Jena

04103

University Hospital Leipzig - Dep. of Anesthesiology and Intensive Care Medicine, Leipzig

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biosyn

INDUSTRY

collaborator

Brahms AG

INDUSTRY

lead

Kompetenznetz Sepsis

NETWORK

NCT00832039 - Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis | Biotech Hunter | Biotech Hunter