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Severe SepsisPhase 3SISPCTNCT00832039

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

A Phase 3 study testing sodium-selenite and Procalcitonin guided therapy in people with Severe Sepsis and Septic Shock, run by Kompetenznetz Sepsis at 35 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Sepsis, Septic Shock
What is being tested?
sodium-selenite and Procalcitonin guided therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,089 participants
Where
35 sitesGermany
Study dates
Nov 2009to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Severe sepsis or septic shock according to ACCP/SCCM criteria
  • Onset of severe sepsis or septic shock <24 h
  • Age >= 18 years
  • Informed consent

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Germany35 sites

  • University Hospital Aachen - Dep. of Intensive Care Medicine

    Aachen, 52074

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

    Augsburg, 86156

  • Klinikum Augsburg - Dep. of Medicine I

    Augsburg, 86156

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

    Berlin, 10115

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

    Berlin, 10117

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

    Berlin, 12313

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

    Berlin, 12559

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

    Berlin, 13353

  • Ev. Krankenhaus Gilead - Dep. of Anesthesiology

    Bielefeld, 33617

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

    Bonn, 53105

  • University Hospital Köln - Dep. of Medicine I

    Cologne, 50924

  • Krankenhaus Dresden-Friedrichstadt

    Dresden, 01067

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

    Dresden, 01307

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

    Erfurt, 99089

  • University Erlangen-Nürnberg - Dep. of Medicine IV

    Erlangen, 91054

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

    Frankfurt am Main, 60590

  • University Hospital Freiburg- Dep. of Surgery

    Freiburg im Breisgau, 79106

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

    Göttingen, 37075

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

    Greifswald, 17475

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

    Halle, 06097

  • University Hospital Halle - Dep. of Medicine III

    Halle, 06120

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

    Hamburg, 20246

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

    Heide, 25746

  • University Hospital Heidelberg - study center Anesthesiology/Surgery

    Heidelberg, 69120

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

    Jena, 07747

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

    Kiel, 24105

  • St. Elisabeth-Krankenhaus - Dep. of Anesthesiology

    Köln-Hohenlind, 50935

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

    Leipzig, 04103

  • University Hospital Mannheim - Dep. of Medicine I

    Mannheim, 68167

  • Krankenhaus München-Neuperlach - Dep. of Anesthesiology

    München, 81737

  • University Hospital Munich - Dep. of Internal Medicine

    Munich, 80336

  • University Hospital Munich - Dep. of Anaesthesiology

    Munich, 81377

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

    Munich, 81545

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

    Münster, 48149

  • Klinikum Oldenburg GmbH - Dep. of Anesthesiology

    Oldenburg, 26133

Other trials in Germany

About this study

Official title: 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.

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.

Read the detailed description

This is a multicenter trial of the German Network Sepsis (SepNet) on patients with severe sepsis or septic shock. This study is supported by unrestricted grants.

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.

Being tested
sodium-selenite, Placebo, Procalcitonin guided therapy
Keywords
sepsis, adjunctive therapy, sodium-selenite, procalcitonin
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sodium-seleniteDrug

    Also called selenase T

    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.

  • PlaceboDrug

    Also called 0.9 % sodium chlorid

    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 therapyProcedure or surgery

    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.

Study groups in NCT00832039
Study groupRoleWhat they receive
SelPCTActive comparatorPatient receives sodium-selenite; causal therapy is guided by a PCT based algorithm.
Receives: Drug: sodium-selenite; Procedure: Procalcitonin guided therapy
SelKonActive comparatorPatient receives sodium-selenite; causal therapy is not guided by a PCT based algorithm.
Receives: Drug: sodium-selenite
PlacPCTPlacebo comparatorPatient receives placebo; causal therapy is guided by a PCT based algorithm.
Receives: Drug: Placebo; Procedure: Procalcitonin guided therapy
PlacKonPlacebo comparatorPatient receives placebo; causal therapy is not guided by a PCT based algorithm.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Measured: 28 days

Secondary outcomes (16)

  1. Mean total SOFA and SOFA subscores

    Measured: study duration

  2. All cause mortality

    Measured: 90 days

  3. Frequency and duration of mechanical ventilation

    Measured: 90 days

  4. Frequency and duration of vasopressor support

    Measured: 90 days

  5. Frequency of adverse events and severe adverse events

    Measured: study duration

  6. Clinical cure and microbiological cure

    Measured: days 4, 7, 10, 14

  7. Duration of antimicrobial therapy

    Measured: study duration

  8. Costs of antimicrobial therapy

    Measured: study duration

  9. Time to change of antibiotic therapy

    Measured: duration of study

  10. Days alive without antimicrobial therapy

    Measured: study duration

  11. Frequency of resistancies against antibiotics (VRE, MRSA, ESBL)

    Measured: study duration

  12. ICU length of stay

    Measured: 90 days

  13. Hospital length of stay

    Measured: 90 days

  14. Rate of surgical procedures for focus control

    Measured: study duration

  15. Rate of procedures to diagnose infections

    Measured: study duration

  16. Frequency of new infections

    Measured: study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionMar 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,089 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00832039
Sponsor's protocol ID
EudraCT 2007-004333-42
Other IDs
01 KI 01 06, SE120301S
Acronym
SISPCT
Status last verified
Aug 2016
First submitted
28 Jan 2009
Last updated
12 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27428731

  • Neumann C, Bloos F, Franken P, Lehmann T, Bogatsch H, Ruhe J; Sepnet Critical Care Trials Group. Predictive performance of kinetic eGFR, midregional proadrenomedullin, and H3.1 nucleosomes for acute kidney disease in sepsis: a secondary analysis of a large multicentre randomized controlled trial. J Intensive Care. 2026 Aug 19;14(1):62. doi: 10.1186/s40560-026-00926-y.

    PubMed 42618952

  • Neumann C, Bloos F, Hla TTW, Bygott T, Bogatsch H, Kiehntopf M, Borner F, Press AT, Bauer M, Retter A; SepNet Critical Care Trials Group. H3.1 Nucleosomes to Predict Renal Replacement Therapy and Mortality in Sepsis-A Secondary Analysis of the SISPCT Randomized Control Trial. Crit Care Med. 2026 Aug 3. doi: 10.1097/CCM.0000000000007270. Online ahead of print.

    PubMed 42545097

  • 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.

    PubMed 31102938

  • 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.

    PubMed 29379043

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sodium-selenite and Procalcitonin guided therapy in people with Severe Sepsis and Septic Shock, run by Kompetenznetz Sepsis at 35 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00832039, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.

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