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Human disease: disease by infectious agent11
Effect of a multifaceted educational intervention for anti-infectious measures on sepsis mortality: a cluster randomized trial
SepNet - German Competence Network Sepsis

Abstract (Expand)

PURPOSE Guidelines recommend administering antibiotics within 1 h of sepsis recognition but this recommendation remains untested by randomized trials. This trial was set up to investigate whether …r survival is improved by reducing the time before initiation of antimicrobial therapy by means of a multifaceted intervention in compliance with guideline recommendations. METHODS The MEDUSA study, a prospective multicenter cluster-randomized trial, was conducted from July 2011 to July 2013 in 40 German hospitals. Hospitals were randomly allocated to receive conventional continuous medical education (CME) measures (control group) or multifaceted interventions including local quality improvement teams, educational outreach, audit, feedback, and reminders. We included 4183 patients with severe sepsis or septic shock in an intention-to-treat analysis comparing the multifaceted intervention (n = 2596) with conventional CME (n = 1587). The primary outcome was 28-day mortality. RESULTS The 28-day mortality was 35.1% (883 of 2596 patients) in the intervention group and 26.7% (403 of 1587 patients; p = 0.01) in the control group. The intervention was not a risk factor for mortality, since this difference was present from the beginning of the study and remained unaffected by the intervention. Median time to antimicrobial therapy was 1.5 h (interquartile range 0.1-4.9 h) in the intervention group and 2.0 h (0.4-5.9 h; p = 0.41) in the control group. The risk of death increased by 2% per hour delay of antimicrobial therapy and 1% per hour delay of source control, independent of group assignment. CONCLUSIONS Delay in antimicrobial therapy and source control was associated with increased mortality but the multifaceted approach was unable to change time to antimicrobial therapy in this setting and did not affect survival.

Authors: Frank Bloos, Hendrik Rüddel, Daniel Thomas-Rüddel, Daniel Schwarzkopf, Christine Pausch, Stephan Harbarth, Torsten Schreiber, Matthias Gründling, John Marshall, Philipp Simon, Mitchell M. Levy, Manfred Weiss, Andreas Weyland, Herwig Gerlach, Tobias Schürholz, Christoph Engel, Claudia Matthäus-Krämer, Christian Scheer, Friedhelm Bach, Reimer Riessen, Bernhard Poidinger, Karin Dey, Norbert Weiler, Andreas Meier-Hellmann, Helene H. Häberle, Gabriele Wöbker, Udo X. Kaisers, Konrad Reinhart

Date Published: 1st Nov 2017

Publication Type: Journal article

Human Diseases: disease by infectious agent

Effect of Hydrocortisone on Development of Shock Among Patients With Severe Sepsis: The HYPRESS Randomized Clinical Trial.
SepNet - German Competence Network Sepsis

Abstract (Expand)

Importance: Adjunctive hydrocortisone therapy is suggested by the Surviving Sepsis Campaign in refractory septic shock only. The efficacy of hydrocortisone in patients with severe sepsis without shock … remains controversial. Objective: To determine whether hydrocortisone therapy in patients with severe sepsis prevents the development of septic shock. Design, Setting, and Participants: Double-blind, randomized clinical trial conducted from January 13, 2009, to August 27, 2013, with a follow-up of 180 days until February 23, 2014. The trial was performed in 34 intermediate or intensive care units of university and community hospitals in Germany, and it included 380 adult patients with severe sepsis who were not in septic shock. Interventions: Patients were randomly allocated 1:1 either to receive a continuous infusion of 200 mg of hydrocortisone for 5 days followed by dose tapering until day 11 (n = 190) or to receive placebo (n = 190). Main Outcomes and Measures: The primary outcome was development of septic shock within 14 days. Secondary outcomes were time until septic shock, mortality in the intensive care unit or hospital, survival up to 180 days, and assessment of secondary infections, weaning failure, muscle weakness, and hyperglycemia (blood glucose level >150 mg/dL [to convert to millimoles per liter, multiply by 0.0555]). Results: The intention-to-treat population consisted of 353 patients (64.9% male; mean [SD] age, 65.0 [14.4] years). Septic shock occurred in 36 of 170 patients (21.2%) in the hydrocortisone group and 39 of 170 patients (22.9%) in the placebo group (difference, -1.8%; 95% CI, -10.7% to 7.2%; P = .70). No significant differences were observed between the hydrocortisone and placebo groups for time until septic shock; mortality in the intensive care unit or in the hospital; or mortality at 28 days (15 of 171 patients [8.8%] vs 14 of 170 patients [8.2%], respectively; difference, 0.5%; 95% CI, -5.6% to 6.7%; P = .86), 90 days (34 of 171 patients [19.9%] vs 28 of 168 patients [16.7%]; difference, 3.2%; 95% CI, -5.1% to 11.4%; P = .44), and 180 days (45 of 168 patients [26.8%] vs 37 of 167 patients [22.2%], respectively; difference, 4.6%; 95% CI, -4.6% to 13.7%; P = .32). In the hydrocortisone vs placebo groups, 21.5% vs 16.9% had secondary infections, 8.6% vs 8.5% had weaning failure, 30.7% vs 23.8% had muscle weakness, and 90.9% vs 81.5% had hyperglycemia. Conclusions and Relevance: Among adults with severe sepsis not in septic shock, use of hydrocortisone compared with placebo did not reduce the risk of septic shock within 14 days. These findings do not support the use of hydrocortisone in these patients. Trial Registration: clinicaltrials.gov Identifier: NCT00670254.

Authors: D. Keh, E. Trips, G. Marx, S. P. Wirtz, E. Abduljawwad, S. Bercker, H. Bogatsch, J. Briegel, C. Engel, H. Gerlach, A. Goldmann, S. O. Kuhn, L. Huter, A. Meier-Hellmann, A. Nierhaus, S. Kluge, J. Lehmke, M. Loeffler, M. Oppert, K. Resener, D. Schadler, T. Schuerholz, P. Simon, N. Weiler, A. Weyland, K. Reinhart, F. M. Brunkhorst

Date Published: 1st Nov 2016

Publication Type: Journal article

Human Diseases: disease by infectious agent

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

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

Date Published: 1st Sep 2016

Publication Type: Journal article

Human Diseases: disease by infectious agent

Enteral nutrition is associated with improved outcome in patients with severe sepsis. A secondary analysis of the VISEP trial.
SepNet - German Competence Network Sepsis

Abstract (Expand)

INTRODUCTION: The optimal nutritional strategy remains controversial, particularly in severely septic patients. Our aim was to analyze the effect of three nutritional strategies--enteral (EN), parenteral … (PN), and combined nutrition (EN+PN)--on the outcome of patients with severe sepsis or septic shock. PATIENTS AND METHODS: This secondary analysis of the prospective, randomized-controlled, multicenter "Intensive Insulin Therapy and Pentastarch Resuscitation in Severe Sepsis (VISEP)" trial only included patients with a length of stay in the intensive care unit (ICU) of more than 7 days. Besides patient characteristics, data on nutrition therapy were collected daily for up to 21 days. Morbidity as measured by the mean Sequential Organ Failure Assessment (SOFA) score, incidence of secondary infections, renal replacement therapy, ventilator-free days and severe hypoglycemia, length of ICU stay, and mortality at 90 days were compared between the three nutritional strategies. RESULTS: In all, 353 patients were included in the analysis with the majority (68.5 %) receiving EN+PN, 24.4 % receiving EN, and only 7.1 % receiving PN. Median caloric intake was 918 kcal/day (EN), 1,210 kcal/day (PN), and 1,343 kcal/day (EN+PN; p < 0.001). In the latter group, calories were predominantly administered via the parenteral route within the first week. The rate of death at 90 days was lower with EN than with EN+PN (26.7 % vs. 41.3 %, p = 0.048), as was the rate of secondary infections, renal replacement therapy, and duration of mechanical ventilation. In the adjusted Cox regression analysis, the effect on mortality [hazard ratio (HR)= 1.86, 95 % confidence interval (CI): 1.16-2.98, p = 0.010] and the rate of secondary infections (HR= 1.89, 95 % CI: 1.27-2.81, p = 0.002) remained different between EN and EN+PN. CONCLUSION: In patients with severe sepsis or septic shock and prolonged ICU stay, EN alone was associated with improved clinical outcome compared to EN+PN. This hypothesis-generating result has to be confirmed by a randomized-controlled trial in this specific patient population.

Authors: G. Elke, E. Kuhnt, M. Ragaller, D. Schadler, I. Frerichs, F. M. Brunkhorst, M. Loffler, K. Reinhart, N. Weiler

Date Published: 5th Mar 2013

Publication Type: Not specified

Human Diseases: disease by infectious agent

Gene polymorphisms in the heme degradation pathway and outcome of severe human sepsis
SepNet - German Competence Network Sepsis

Abstract (Expand)

Heme and its breakdown products CO, Fe, and bilirubin are being recognized as signaling molecules or even therapeutic agents, but also exert adverse effects when released at high concentrations. … Manipulating the pathway confers protection in rodent sepsis models via both control of free heme and formation of its first and higher-order products. Thus, regulatory elements present in human heme oxygenase 1 (HMOX1) and biliverdin reductases (BLVRA/B) genes might impact outcome. We tested whether a highly polymorphic (GT)n microsatellite and single-nucleotide polymorphisms in HMOX1 and BLVRA/B genes are associated with outcome of sepsis. Two cohorts (n = 430 and 398 patients) with severe sepsis were screened for single-nucleotide polymorphisms and/or the microsatellite by fragment length analysis and genotyping techniques. Heme oxygenase 1 plasma levels were determined in additional patients with severe sepsis (n = 92) by enzyme-linked immunosorbent assay. Based on mean Sepsis-related Organ Failure Assessment scores, patients homozygous for rs2071746 A allele or medium length (GT)n microsatellites of HMOX1 showed higher 28-day mortality (P = 0.047 and P = 0.033) in one cohort compared with other genotypes, whereas 90-day mortality rates showed no association. The T allele was less frequently observed in both cohorts than would be expected according to Hardy-Weinberg equilibrium. Heme oxygenase 1 plasma levels were elevated in septic patients, independent of the genotype. Single-nucleotide polymorphisms within BLVRA/B showed no association with outcome. Short (GT)n repeats that are in linkage disequilibrium with the T allele of rs2071746 in HMOX1 are associated with favorable outcome, whereas no association with gene variants of BLVRA/B, involved in the generation of higher-order metabolites, was noticed.

Authors: Christoph Sponholz, Klaus Huse, Marcel Kramer, Evangelos J. Giamarellos-Bourboulis, Ralf A. Claus, Anna Kern, Christoph Engel, Evelyn Kuhnt, Michael Kiehntopf, Christina Routsi, Vassiliki Mylona, Iraklis Tsangaris, Stefan H. Heinemann, Konrad Reinhart, Matthias Platzer, Michael Bauer

Date Published: 2012

Publication Type: Journal article

Human Diseases: disease by infectious agent

Variability of structures in German intensive care units–a representative, nationwide analysis
SepNet - German Competence Network Sepsis

Abstract (Expand)

BACKGROUND Structures in intensive care medicine comprise human as well as material resources, organization, and management and may be related to processes thereby affecting patients’ outcomes. Utilizing …g a unique data base we evaluated structures of German intensive care units (ICUs). METHODS The study was carried out by the German Competence Network Sepsis (SepNet). Data were prospectively collected on a cross-sectional basis in a representative random sample of German hospitals utilizing a questionnaire. Structures were related to ICU outcome of patients with severe sepsis or septic shock. The sample was subdivided in 5 strata according to hospital size. RESULTS A total of 454 ICUs cared for 3877 patients including 415 patients (11%) with severe sepsis or septic shock. The mean number of beds per ICU was 10.4, the ratio of ICU to hospital beds 1:27, both with significant differences depending on hospital size. 81% of the ICUs provided around the clock physician presence (range: 66-98% across hospital strata, p \textless 0.001). Shift-wise, one nurse was responsible for a mean number of 2.7 patients (morning 1:2.3, afternoon 1:2.6, night 1:3.3 patients) with significant variation according to hospital size (smaller hospitals 1:2.9, university hospitals 1:2.1, p \textless 0.001). More than half of all German ICUs are lead by anesthesiologists. Neither physician nor nurse staffing was associated with mortality in the subset of patients with sepsis. CONCLUSIONS In a representative, nationwide sample of German ICUs key elements of structures varied considerably with respect to hospital size. This has to be considered when proposing standards, reimbursement strategies, or quality assessment.

Authors: Jürgen Graf, Andrea Reinhold, Frank M. Brunkhorst, Max Ragaller, Konrad Reinhart, Markus Loeffler, Christoph Engel

Date Published: 1st Oct 2010

Publication Type: Journal article

Human Diseases: disease by infectious agent

Practice of volume therapy in patients with severe sepsis: results from a nationwide sepsis prevalence study
SepNet - German Competence Network Sepsis

Abstract

Not specified

Authors: Christiane S. Hartog, Frank M. Brunkhorst, Frank Bloos, Holger Bogatsch, Christoph Engel, Kerstin Sengebusch, Konrad Reinhart, Maximilian Ragaller

Date Published: 1st Mar 2010

Publication Type: Journal article

Human Diseases: disease by infectious agent

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