Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis
NCT ID: NCT00832039
Last Updated: 2016-08-12
Study Results
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Basic Information
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COMPLETED
PHASE3
1089 participants
INTERVENTIONAL
2009-11-30
2013-06-30
Brief Summary
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Detailed Description
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The release of reactive oxygen species is an important factor in the development of sepsis induced multiorgan dysfunction syndrome. Common protection mechanisms are impaired in this syndrome. Serum levels of selenium, a cofactor of the glutathionperoxidase, are reduced. Several studies suggest a benefit of selenium application in patients with severe sepsis but data from large clinical trials are not available. After inclusion into the study, patients are randomly allocated to a placebo or selenium group. Treating physicians and patients are blinded regarding the allocation. The selenium group receives sodium selenite intravenously - 1000 µg as a bolus followed by a continuous infusion of 1000 µg per day until the end of ICU treatment but not longer than 21 days.
Procalcitonin (PCT) is a biomarker which is elevated in the blood of patients with severe sepsis/septic shock. Data from patients with community acquired pneumonia demonstrated that this biomarker can be used to decide on the duration of antimicrobial therapy. Studies with small sample size seem to confirm this in ICU patients with severe sepsis. However, this needs to be confirmed in a larger cohort. All patients are randomly allocated to a PCT guided algorithm or a control group. In the PCT-guided group, PCT is measured at randomization, day 4, 7, 10, and 14. Depending on the PCT course, the protocol recommends to change, alter, or stop anti-infectious measures. In the control group, anti-infectious therapy is left to the discretion of the treating physician.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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SelPCT
Patient receives sodium-selenite; causal therapy is guided by a PCT based algorithm.
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.
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.
SelKon
Patient receives sodium-selenite; causal therapy is not guided by a PCT based algorithm.
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.
PlacPCT
Patient receives placebo; causal therapy is guided by a PCT based algorithm.
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.
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.
PlacKon
Patient receives placebo; causal therapy is not guided by a PCT based algorithm.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Onset of severe sepsis or septic shock \<24 h
* Age \>= 18 years
* Informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Biosyn
INDUSTRY
Brahms AG
INDUSTRY
Kompetenznetz Sepsis
NETWORK
Responsible Party
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Principal Investigators
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Konrad Reinhart, M.D.
Role: STUDY_CHAIR
University Hospital Jena; Dep. of Anesthesiology and Intensive Care Medicine
Markus Löffler
Role: STUDY_DIRECTOR
University Leipzig; Koordinierungszentrum für Klinische Studien Leipzig (KKSL)
Thomas Deufel, M. D.
Role: STUDY_DIRECTOR
University Hopitel Jena, Institute for Medical Chemistry
Locations
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University Hospital Aachen - Dep. of Intensive Care Medicine
Aachen, , Germany
Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine
Augsburg, , Germany
Klinikum Augsburg - Dep. of Medicine I
Augsburg, , Germany
Military Hospital Berlin - Dep. of Anaesthesiology and Intensive Care Medicine
Berlin, , Germany
Charité Berlin - Dep. of Anesthesiology and Intensive Care Medicine
Berlin, , Germany
Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
Berlin, , Germany
DRK-Kliniken Berlin-Köpenick - Dep. of Anesthesiology, Pain Therapy, and Intensive Care Medicine
Berlin, , Germany
Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology
Berlin, , Germany
Ev. Krankenhaus Gilead - Dep. of Anesthesiology
Bielefeld, , Germany
University Hospital Bonn - Dep. of Anesthesiology and Intensive Care Medicine
Bonn, , Germany
University Hospital Köln - Dep. of Medicine I
Cologne, , Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, , Germany
University Hospital Dresden - Dep. of Anesthesiology and Intensive Care Med.
Dresden, , Germany
HELIOS Klinikum Erfurt - Dep. of Anesthesiology and Intensive Care Medicine
Erfurt, , Germany
University Erlangen-Nürnberg - Dep. of Medicine IV
Erlangen, , Germany
J.-W. Goethe University Hospital - Dep. of Anaesthesiology, Intensive Care Medicine and Pain Therapy
Frankfurt am Main, , Germany
University Hospital Freiburg- Dep. of Surgery
Freiburg im Breisgau, , Germany
Georg August Universität Göttingen - Dep. of Anesthesiology and Intensive Care Medicine
Göttingen, , Germany
Ernst-Moritz-Arndt-Universität Greifswald - Dep. of Anesthesiology and Intensive Care Medicine
Greifswald, , Germany
Martin-Luther-Universität Halle-Wittenberg - Dep. of Anesthesiology
Halle, , Germany
University Hospital Halle - Dep. of Medicine III
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf - Dep. of Intensive Care Medicine
Hamburg, , Germany
Westküstenklinikum Heide - Dep. of Anesthesiology and Intensive Care Medicine
Heide, , Germany
University Hospital Heidelberg - study center Anesthesiology/Surgery
Heidelberg, , Germany
University Hospital Jena, Dep. of Anesthesiology and Intensive Care Medicine
Jena, , Germany
University Hospital Kiel - Dep. of. Anesthesiology and Intensive Care Medicine
Kiel, , Germany
St. Elisabeth-Krankenhaus - Dep. of Anesthesiology
Köln-Hohenlind, , Germany
University Hospital Leipzig - Dep. of Anesthesiology and Intensive Care Medicine
Leipzig, , Germany
University Hospital Mannheim - Dep. of Medicine I
Mannheim, , Germany
University Hospital Munich - Dep. of Internal Medicine
Munich, , Germany
University Hospital Munich - Dep. of Anaesthesiology
Munich, , Germany
Hospital Munich Harlaching - Dep. of Internal Acute Medicine and Prevention
Munich, , Germany
Krankenhaus München-Neuperlach - Dep. of Anesthesiology
München, , Germany
University Hospital Münster - Dep. of Anesthesiology and Intensive Care Medicine
Münster, , Germany
Klinikum Oldenburg GmbH - Dep. of Anesthesiology
Oldenburg, , Germany
Countries
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References
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Bloos F, Trips E, Nierhaus A, Briegel J, Heyland DK, Jaschinski U, Moerer O, Weyland A, Marx G, Grundling M, Kluge S, Kaufmann I, Ott K, Quintel M, Jelschen F, Meybohm P, Rademacher S, Meier-Hellmann A, Utzolino S, Kaisers UX, Putensen C, Elke G, Ragaller M, Gerlach H, Ludewig K, Kiehntopf M, Bogatsch H, Engel C, Brunkhorst FM, Loeffler M, Reinhart K; for SepNet Critical Care Trials Group. Effect of Sodium Selenite Administration and Procalcitonin-Guided Therapy on Mortality in Patients With Severe Sepsis or Septic Shock: A Randomized Clinical Trial. JAMA Intern Med. 2016 Sep 1;176(9):1266-76. doi: 10.1001/jamainternmed.2016.2514.
Guo A, Srinath J, Feuerecker M, Crucian B, Briegel J, Boulesteix AL, Kaufmann I, Chouker A. Immune function testing in sepsis patients receiving sodium selenite. J Crit Care. 2019 Aug;52:208-212. doi: 10.1016/j.jcrc.2019.05.001. Epub 2019 May 4.
Feuerecker M, Sudhoff L, Crucian B, Pagel JI, Sams C, Strewe C, Guo A, Schelling G, Briegel J, Kaufmann I, Chouker A. Early immune anergy towards recall antigens and mitogens in patients at onset of septic shock. Sci Rep. 2018 Jan 29;8(1):1754. doi: 10.1038/s41598-018-19976-w.
Related Links
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German Sepsis Society
Competence Network Sepsis (SepNet)
Surviving Sepsis Campaign
Other Identifiers
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01 KI 01 06
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SE120301S
Identifier Type: OTHER
Identifier Source: secondary_id
EudraCT 2007-004333-42
Identifier Type: -
Identifier Source: org_study_id
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