Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis
SISPCT
Prospective, Randomized Multicenter Trial of Adjunctive Intravenous Therapy With Sodium-selenite(Selenase®, Double-blinded) and a Procalcitonin Guided Causal Therapy (Open) of Severe Sepsis or Septic Shock.
3 other identifiers
interventional
1,089
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2009
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2009
CompletedFirst Posted
Study publicly available on registry
January 29, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 12, 2016
August 1, 2016
3.3 years
January 28, 2009
August 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All cause mortality
28 days
Secondary Outcomes (16)
Mean total SOFA and SOFA subscores
study duration
All cause mortality
90 days
Frequency and duration of mechanical ventilation
90 days
Frequency and duration of vasopressor support
90 days
Frequency of adverse events and severe adverse events
study duration
- +11 more secondary outcomes
Study Arms (4)
SelPCT
ACTIVE COMPARATORPatient receives sodium-selenite; causal therapy is guided by a PCT based algorithm.
SelKon
ACTIVE COMPARATORPatient receives sodium-selenite; causal therapy is not guided by a PCT based algorithm.
PlacPCT
PLACEBO COMPARATORPatient receives placebo; causal therapy is guided by a PCT based algorithm.
PlacKon
PLACEBO COMPARATORPatient receives placebo; causal therapy is not guided by a PCT based algorithm.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Severe sepsis or septic shock according to ACCP/SCCM criteria
- Onset of severe sepsis or septic shock \<24 h
- Age \>= 18 years
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kompetenznetz Sepsislead
- Biosyncollaborator
- Brahms AGcollaborator
Study Sites (35)
University Hospital Aachen - Dep. of Intensive Care Medicine
Aachen, 52074, Germany
Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine
Augsburg, 86156, Germany
Klinikum Augsburg - Dep. of Medicine I
Augsburg, 86156, Germany
Military Hospital Berlin - Dep. of Anaesthesiology and Intensive Care Medicine
Berlin, 10115, Germany
Charité Berlin - Dep. of Anesthesiology and Intensive Care Medicine
Berlin, 10117, Germany
Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
Berlin, 12313, Germany
DRK-Kliniken Berlin-Köpenick - Dep. of Anesthesiology, Pain Therapy, and Intensive Care Medicine
Berlin, 12559, Germany
Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology
Berlin, 13353, Germany
Ev. Krankenhaus Gilead - Dep. of Anesthesiology
Bielefeld, 33617, Germany
University Hospital Bonn - Dep. of Anesthesiology and Intensive Care Medicine
Bonn, 53105, Germany
University Hospital Köln - Dep. of Medicine I
Cologne, 50924, Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, 01067, Germany
University Hospital Dresden - Dep. of Anesthesiology and Intensive Care Med.
Dresden, 01307, Germany
HELIOS Klinikum Erfurt - Dep. of Anesthesiology and Intensive Care Medicine
Erfurt, 99089, Germany
University Erlangen-Nürnberg - Dep. of Medicine IV
Erlangen, 91054, Germany
J.-W. Goethe University Hospital - Dep. of Anaesthesiology, Intensive Care Medicine and Pain Therapy
Frankfurt am Main, 60590, Germany
University Hospital Freiburg- Dep. of Surgery
Freiburg im Breisgau, 79106, Germany
Georg August Universität Göttingen - Dep. of Anesthesiology and Intensive Care Medicine
Göttingen, 37075, Germany
Ernst-Moritz-Arndt-Universität Greifswald - Dep. of Anesthesiology and Intensive Care Medicine
Greifswald, 17475, Germany
Martin-Luther-Universität Halle-Wittenberg - Dep. of Anesthesiology
Halle, 06097, Germany
University Hospital Halle - Dep. of Medicine III
Halle, 06120, Germany
Universitätsklinikum Hamburg-Eppendorf - Dep. of Intensive Care Medicine
Hamburg, 20246, Germany
Westküstenklinikum Heide - Dep. of Anesthesiology and Intensive Care Medicine
Heide, 25746, Germany
University Hospital Heidelberg - study center Anesthesiology/Surgery
Heidelberg, 69120, Germany
University Hospital Jena, Dep. of Anesthesiology and Intensive Care Medicine
Jena, 07747, Germany
University Hospital Kiel - Dep. of. Anesthesiology and Intensive Care Medicine
Kiel, 24105, Germany
St. Elisabeth-Krankenhaus - Dep. of Anesthesiology
Köln-Hohenlind, 50935, Germany
University Hospital Leipzig - Dep. of Anesthesiology and Intensive Care Medicine
Leipzig, 04103, Germany
University Hospital Mannheim - Dep. of Medicine I
Mannheim, 68167, Germany
University Hospital Munich - Dep. of Internal Medicine
Munich, 80336, Germany
University Hospital Munich - Dep. of Anaesthesiology
Munich, 81377, Germany
Hospital Munich Harlaching - Dep. of Internal Acute Medicine and Prevention
Munich, 81545, Germany
Krankenhaus München-Neuperlach - Dep. of Anesthesiology
München, 81737, Germany
University Hospital Münster - Dep. of Anesthesiology and Intensive Care Medicine
Münster, 48149, Germany
Klinikum Oldenburg GmbH - Dep. of Anesthesiology
Oldenburg, 26133, Germany
Related Publications (3)
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.
PMID: 27428731RESULTGuo 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.
PMID: 31102938DERIVEDFeuerecker 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.
PMID: 29379043DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Konrad Reinhart, M.D.
University Hospital Jena; Dep. of Anesthesiology and Intensive Care Medicine
- STUDY DIRECTOR
Markus Löffler
University Leipzig; Koordinierungszentrum für Klinische Studien Leipzig (KKSL)
- STUDY DIRECTOR
Thomas Deufel, M. D.
University Hopitel Jena, Institute for Medical Chemistry
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2009
First Posted
January 29, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
August 12, 2016
Record last verified: 2016-08