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

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Effect of Sodium Selenite Administration and Procalcitonin-Guided Therapy on Mortality in Patients With Severe Sepsis or Septic Shock: A Randomized Clinical Trial. / Bloos, Frank; Trips, Evelyn; Nierhaus, Axel; Briegel, Josef; Heyland, Daren K; Jaschinski, Ulrich; Moerer, Onnen; Weyland, Andreas; Marx, Gernot; Gründling, Matthias; Kluge, Stefan; Kaufmann, Ines; Ott, Klaus; Quintel, Michael; Jelschen, Florian; Meybohm, Patrick; Rademacher, Sibylle; Meier-Hellmann, Andreas; Utzolino, Stefan; Kaisers, Udo X; Putensen, Christian; Elke, Gunnar; Ragaller, Maximilian; Gerlach, Herwig; Ludewig, Katrin; Kiehntopf, Michael; Bogatsch, Holger; Engel, Christoph; Brunkhorst, Frank M; Loeffler, Markus; Reinhart, Konrad; SepNet Critical Care Trials Group.

In: JAMA INTERN MED, Vol. 176, No. 9, 01.09.2016, p. 1266-1276.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Bloos, F, Trips, E, Nierhaus, A, Briegel, J, Heyland, DK, Jaschinski, U, Moerer, O, Weyland, A, Marx, G, Gründling, 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 & SepNet Critical Care Trials Group 2016, '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, vol. 176, no. 9, pp. 1266-1276. https://doi.org/10.1001/jamainternmed.2016.2514

APA

Bloos, F., Trips, E., Nierhaus, A., Briegel, J., Heyland, D. K., Jaschinski, U., Moerer, O., Weyland, A., Marx, G., Gründling, M., Kluge, S., Kaufmann, I., Ott, K., Quintel, M., Jelschen, F., Meybohm, P., Rademacher, S., Meier-Hellmann, A., Utzolino, S., ... SepNet Critical Care Trials Group (2016). 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, 176(9), 1266-1276. https://doi.org/10.1001/jamainternmed.2016.2514

Vancouver

Bloos F, Trips E, Nierhaus A, Briegel J, Heyland DK, Jaschinski U et al. 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):1266-1276. https://doi.org/10.1001/jamainternmed.2016.2514

Bibtex

@article{816e76d1a177479fa3b921ace50145fc,
title = "Effect of Sodium Selenite Administration and Procalcitonin-Guided Therapy on Mortality in Patients With Severe Sepsis or Septic Shock: A Randomized Clinical Trial",
abstract = "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 × 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 µg, followed by a continuous intravenous infusion of sodium selenite, 1000 µg, 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.",
author = "Frank Bloos and Evelyn Trips and Axel Nierhaus and Josef Briegel and Heyland, {Daren K} and Ulrich Jaschinski and Onnen Moerer and Andreas Weyland and Gernot Marx and Matthias Gr{\"u}ndling and Stefan Kluge and Ines Kaufmann and Klaus Ott and Michael Quintel and Florian Jelschen and Patrick Meybohm and Sibylle Rademacher and Andreas Meier-Hellmann and Stefan Utzolino and Kaisers, {Udo X} and Christian Putensen and Gunnar Elke and Maximilian Ragaller and Herwig Gerlach and Katrin Ludewig and Michael Kiehntopf and Holger Bogatsch and Christoph Engel and Brunkhorst, {Frank M} and Markus Loeffler and Konrad Reinhart and {SepNet Critical Care Trials Group}",
year = "2016",
month = sep,
day = "1",
doi = "10.1001/jamainternmed.2016.2514",
language = "English",
volume = "176",
pages = "1266--1276",
journal = "JAMA INTERN MED",
issn = "2168-6106",
publisher = "American Medical Association",
number = "9",

}

RIS

TY - JOUR

T1 - Effect of Sodium Selenite Administration and Procalcitonin-Guided Therapy on Mortality in Patients With Severe Sepsis or Septic Shock: A Randomized Clinical Trial

AU - Bloos, Frank

AU - Trips, Evelyn

AU - Nierhaus, Axel

AU - Briegel, Josef

AU - Heyland, Daren K

AU - Jaschinski, Ulrich

AU - Moerer, Onnen

AU - Weyland, Andreas

AU - Marx, Gernot

AU - Gründling, Matthias

AU - Kluge, Stefan

AU - Kaufmann, Ines

AU - Ott, Klaus

AU - Quintel, Michael

AU - Jelschen, Florian

AU - Meybohm, Patrick

AU - Rademacher, Sibylle

AU - Meier-Hellmann, Andreas

AU - Utzolino, Stefan

AU - Kaisers, Udo X

AU - Putensen, Christian

AU - Elke, Gunnar

AU - Ragaller, Maximilian

AU - Gerlach, Herwig

AU - Ludewig, Katrin

AU - Kiehntopf, Michael

AU - Bogatsch, Holger

AU - Engel, Christoph

AU - Brunkhorst, Frank M

AU - Loeffler, Markus

AU - Reinhart, Konrad

AU - SepNet Critical Care Trials Group

PY - 2016/9/1

Y1 - 2016/9/1

N2 - 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 × 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 µg, followed by a continuous intravenous infusion of sodium selenite, 1000 µg, 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.

AB - 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 × 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 µg, followed by a continuous intravenous infusion of sodium selenite, 1000 µg, 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.

U2 - 10.1001/jamainternmed.2016.2514

DO - 10.1001/jamainternmed.2016.2514

M3 - SCORING: Journal article

C2 - 27428731

VL - 176

SP - 1266

EP - 1276

JO - JAMA INTERN MED

JF - JAMA INTERN MED

SN - 2168-6106

IS - 9

ER -