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SISPCT

Motivation:

High-dose intravenous administration of sodium selenite has been proposed to improve outcome in sepsis by attenuating oxidative stress. Procalcitonin-guided antimicrobial therapy may hasten the diagnosis of sepsis, but effect on outcome is unclear. We investigated whether high-dose intravenous sodium selenite treatment and procalcitonin-guided anti-infectious therapy in patients with severe sepsis affect mortality.

Baseline Data and Endpoints for SISPCT

LHA ID: 7WGHTUDP5M-2

Investigation: SISPCT

Projects: SepNet - German Competence Network Sepsis

Study position:

Study type: Not specified

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Creators and Submitter

Creator

Christoph Engel

Submitter

René Hänsel

Activity

Views: 2509

Created: 20th May 2019 at 13:49

Last updated: 20th May 2019 at 13:51

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Resources (2)
Publications (1)
Data files (5)
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SepNet - German Competence Network Sepsis

As an interdisciplinary network of scientists, the SepNet study group deals with the topics of severe sepsis and septic shock. The aim of the network is to create the prerequisites for better clinical and experimental research into sepsis and thus to develop efficient treatment approaches.

Programme: LIFE Management Cluster

Public web page: https://www.sepsis-stiftung.eu/sepnet/

Start date: 1st Jan 2003

Organisms: Homo sapiens

Human Diseases: disease by infectious agent

SISPCT

SepNet - German Competence Network Sepsis

All creators

Christoph Engel

No description specified

Submitter: René Hänsel

Studies: SISPCT

Resources: SISPCT Trail Data, SISPCT Trail Metadata

Snapshots: No snapshots

Created: 20th May 2019 at 13:47, Last updated: 20th May 2019 at 13:48

SISPCT Trail Metadata

SepNet - German Competence Network Sepsis

All creators

Christoph Engel

No description specified

Submitter: René Hänsel

Resource type: Experimental Assay Type

Technology type: Technology Type

Investigation: SISPCT

Study: SISPCT

Human Diseases: disease by infectious agent

Data files: SISPCT Metadata, SISPCT Metadata-ODM

Snapshots: No snapshots

Created: 20th May 2019 at 13:51, Last updated: 29th Oct 2019 at 10:58

SISPCT Trail Data

SepNet - German Competence Network Sepsis

All creators

Christoph Engel

No description specified

Submitter: René Hänsel

Resource type: Experimental Assay Type

Technology type: Technology Type

Investigation: SISPCT

Study: SISPCT

Human Diseases: disease by infectious agent

Data files: SISPCT, SISPCT-ODM, SISPCT-SPSS

Snapshots: No snapshots

Created: 20th May 2019 at 13:52, Last updated: 29th Oct 2019 at 10:58

Effect of Sodium Selenite Administration and Procalcitonin-Guided Therapy on Mortality in Patients With Severe Sepsis or Septic Shock: A Randomized Clinical Trial.

SepNet - German Competence Network Sepsis

(Show All)

All authors

Christoph Engel

Markus Löffler

Konrad Reinhart

Abstract (Expand)

IMPORTANCE: High-dose intravenous administration of sodium selenite has been proposed to improve outcome in sepsis by attenuating oxidative stress. Procalcitonin-guided antimicrobial therapy may hasten … the diagnosis of sepsis, but effect on outcome is unclear. OBJECTIVE: To determine whether high-dose intravenous sodium selenite treatment and procalcitonin-guided anti-infectious therapy in patients with severe sepsis affect mortality. DESIGN, SETTING, AND PARTICIPANTS: The Placebo-Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis (SISPCT), a multicenter, randomized, clinical, 2 x 2 factorial trial performed in 33 intensive care units in Germany, was conducted from November 6, 2009, to June 6, 2013, including a 90-day follow-up period. INTERVENTIONS: Patients were randomly assigned to receive an initial intravenous loading dose of sodium selenite, 1000 microg, followed by a continuous intravenous infusion of sodium selenite, 1000 microg, daily until discharge from the intensive care unit, but not longer than 21 days, or placebo. Patients also were randomized to receive anti-infectious therapy guided by a procalcitonin algorithm or without procalcitonin guidance. MAIN OUTCOMES AND MEASURES: The primary end point was 28-day mortality. Secondary outcomes included 90-day all-cause mortality, intervention-free days, antimicrobial costs, antimicrobial-free days, and secondary infections. RESULTS: Of 8174 eligible patients, 1089 patients (13.3%) with severe sepsis or septic shock were included in an intention-to-treat analysis comparing sodium selenite (543 patients [49.9%]) with placebo (546 [50.1%]) and procalcitonin guidance (552 [50.7%]) vs no procalcitonin guidance (537 [49.3%]). The 28-day mortality rate was 28.3% (95% CI, 24.5%-32.3%) in the sodium selenite group and 25.5% (95% CI, 21.8%-29.4%) (P = .30) in the placebo group. There was no significant difference in 28-day mortality between patients assigned to procalcitonin guidance (25.6% [95% CI, 22.0%-29.5%]) vs no procalcitonin guidance (28.2% [95% CI, 24.4%-32.2%]) (P = .34). Procalcitonin guidance did not affect frequency of diagnostic or therapeutic procedures but did result in a 4.5% reduction of antimicrobial exposure. CONCLUSIONS AND RELEVANCE: Neither high-dose intravenous administration of sodium selenite nor anti-infectious therapy guided by a procalcitonin algorithm was associated with an improved outcome in patients with severe sepsis. These findings do not support administration of high-dose sodium selenite in these patients; the application of a procalcitonin-guided algorithm needs further evaluation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00832039.

Authors: F. Bloos, E. Trips, A. Nierhaus, J. Briegel, D. K. Heyland, U. Jaschinski, O. Moerer, A. Weyland, G. Marx, M. Grundling, S. Kluge, I. Kaufmann, K. Ott, M. Quintel, F. Jelschen, P. Meybohm, S. Rademacher, A. Meier-Hellmann, S. Utzolino, U. X. Kaisers, C. Putensen, G. Elke, M. Ragaller, H. Gerlach, K. Ludewig, M. Kiehntopf, H. Bogatsch, C. Engel, F. M. Brunkhorst, M. Loeffler, K. Reinhart