NCT00832039: 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.

Completed Phase 3 Last updated 11 August 2016

What this trial tests

Phase 3 trial testing sodium-selenite in Severe Sepsis in 1,089 participants. Completed in 1 June 2013.

Timeline

1 November 2009

Primary endpoint
1 March 2013

1 June 2013

Quick facts

Lead sponsor	Kompetenznetz Sepsis
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	1,089
Start date	1 November 2009
Primary completion	1 March 2013
Estimated completion	1 June 2013
Sites	35 locations across Germany

Drugs / interventions tested

• sodium-selenite
• Placebo
• Procalcitonin guided therapy

Conditions studied

• Severe Sepsis — all drugs for Severe Sepsis →
• Septic Shock — all drugs for Septic Shock →

Sponsor

Kompetenznetz Sepsis — full company profile →

Who can join

18 and older, any sex, with Severe Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• All cause mortality
  Time frame: 28 days

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The pathogenesis of sepsis.
   Stearns-Kurosawa DJ, Osuchowski MF, Valentine C, Kurosawa S, et al · · 2011 · cited 441× · PMID 20887193 · DOI 10.1146/annurev-pathol-011110-130327
2. New approaches to sepsis: molecular diagnostics and biomarkers.
   Reinhart K, Bauer M, Riedemann NC, Hartog CS. · · 2012 · cited 328× · PMID 23034322 · DOI 10.1128/cmr.00016-12
3. Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections.
   Schuetz P, Wirz Y, Sager R, Christ-Crain M, et al · · 2017 · cited 206× · PMID 29025194 · DOI 10.1002/14651858.cd007498.pub3
4. Effect of Sodium Selenite Administration and Procalcitonin-Guided Therapy on Mortality in Patients With Severe Sepsis or Septic Shock: A Randomized Clinical Trial.
   Bloos F, Trips E, Nierhaus A, Briegel J, et al · · 2016 · cited 190× · PMID 27428731 · DOI 10.1001/jamainternmed.2016.2514
5. Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections.
   Schuetz P, Müller B, Christ-Crain M, Stolz D, et al · · 2012 · cited 177× · PMID 22972110 · DOI 10.1002/14651858.cd007498.pub2
6. Rapid diagnosis of sepsis.
   Bloos F, Reinhart K. · · 2014 · cited 103× · PMID 24335467 · DOI 10.4161/viru.27393
7. Urosepsis--Etiology, Diagnosis, and Treatment.
   Dreger NM, Degener S, Ahmad-Nejad P, Wöbker G, et al · · 2015 · cited 78× · PMID 26754121 · DOI 10.3238/arztebl.2015.0837
8. The prevalence of sepsis-induced coagulopathy in patients with sepsis - a secondary analysis of two German multicenter randomized controlled trials.
   Schmoch T, Möhnle P, Weigand MA, Briegel J, et al · · 2023 · cited 47× · PMID 36635426 · DOI 10.1186/s13613-022-01093-7