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Human disease: disease by infectious agent8
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

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

Current practice in nutritional support and its association with mortality in septic patients–results from a national, prospective, multicenter study
SepNet - German Competence Network Sepsis

Abstract (Expand)

OBJECTIVE To identify current clinical practice regarding nutrition and its association with morbidity and mortality in patients with severe sepsis or septic shock in Germany. DESIGN Nationwide …ide prospective, observational, cross-sectional, 1-day point-prevalence study. SETTING The study included 454 intensive care units from a representative sample of 310 hospitals stratified by size. PATIENTS Participants were 415 patients with severe sepsis or septic shock (according to criteria of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference). INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Data were collected by on-site audits of trained external study physicians during randomly scheduled visits during 1 yr. Valid data on nutrition were available for 399 of 415 patients. The data showed that 20.1% of patients received exclusively enteral nutrition, 35.1% exclusively parenteral nutrition, and 34.6% mixed nutrition (parenteral and enteral); 10.3% were not fed at all. Patients with gastrointestinal/intra-abdominal infection, pancreatitis or neoplasm of the gastrointestinal tract, mechanical ventilation, or septic shock were less likely to receive exclusively enteral nutrition. Median Acute Physiology and Chronic Health Evaluation II and Sepsis-related Organ Failure Assessment scores were significantly different among the nutrition groups. Overall hospital mortality was 55.2%. Hospital mortality was significantly higher in patients receiving exclusively parenteral (62.3%) or mixed nutrition (57.1%) than in patients with exclusively enteral nutrition (38.9%) (p = .005). After adjustment for patient morbidity (Acute Physiology and Chronic Health Evaluation II score, presence of septic shock) and treatment factors (mechanical ventilation), multivariate analysis revealed that the presence of parenteral nutrition was significantly predictive of mortality (odds ratio, 2.09; 95% confidence interval, 1.29-3.37). CONCLUSIONS Patients with severe sepsis or septic shock in German intensive care units received preferentially parenteral or mixed nutrition. The use of parenteral nutrition was associated with an increased risk of death.

Authors: Gunnar Elke, Dirk Schädler, Christoph Engel, Holger Bogatsch, Inez Frerichs, Maximilian Ragaller, Jens Scholz, Frank M. Brunkhorst, Markus Löffler, Konrad Reinhart, Norbert Weiler

Date Published: 2008

Publication Type: Journal article

Human Diseases: disease by infectious agent

Practice and perception–a nationwide survey of therapy habits in sepsis
SepNet - German Competence Network Sepsis

Abstract (Expand)

OBJECTIVE To simultaneously determine perceived vs. practiced adherence to recommended interventions for the treatment of severe sepsis or septic shock. DESIGN One-day cross-sectional survey. SETTING …TING Representative sample of German intensive care units stratified by hospital size. PATIENTS Adult patients with severe sepsis or septic shock. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Practice recommendations were selected by German Sepsis Competence Network (SepNet) investigators. External intensivists visited intensive care units randomly chosen and asked the responsible intensive care unit director how often these recommendations were used. Responses \textquotedblalways\textquotedbl and \textquotedblfrequently\textquotedbl were combined to depict perceived adherence. Thereafter patient files were audited. Three hundred sixty-six patients on 214 intensive care units fulfilled the criteria and received full support. One hundred fifty-two patients had acute lung injury or acute respiratory distress syndrome. Low-tidal volume ventilation \textless or = 6 mL/kg/predicted body weight was documented in 2.6% of these patients. A total of 17.1% patients had tidal volume between 6 and 8 mL/kg predicted body weight and 80.3% \textgreater 8 mL/kg predicted body weight. Mean tidal volume was 10.0 +/- 2.4 mL/kg predicted body weight. Perceived adherence to low-tidal volume ventilation was 79.9%. Euglycemia (4.4-6.1 mmol/L) was documented in 6.2% of 355 patients. A total of 33.8% of patients had blood glucose levels \textless or = 8.3 mmol/L and 66.2% were hyperglycemic (blood glucose \textgreater 8.3 mmol/L). Among 207 patients receiving insulin therapy, 1.9% were euglycemic, 20.8% had blood glucose levels \textless or = 8.3 mmol/L, and 1.0% were hypoglycemic. Overall, mean maximal glucose level was 10.0 +/- 3.6 mmol/L. Perceived adherence to strict glycemic control was 65.9%. Although perceived adherence to recommendations was higher in academic and larger hospitals, actual practice was not significantly influenced by hospital size or university affiliation. CONCLUSIONS This representative survey shows that current therapy of severe sepsis in German intensive care units complies poorly with practice recommendations. Intensive care unit directors perceive adherence to be higher than it actually is. Implementation strategies involving all intensive care unit staff are needed to overcome this gap between current evidence-based knowledge, practice, and perception.

Authors: Frank M. Brunkhorst, Christoph Engel, Max Ragaller, Tobias Welte, Rolf Rossaint, Herwig Gerlach, Konstantin Mayer, Stefan John, Frank Stuber, Norbert Weiler, Michael Oppert, Onnen Moerer, Holger Bogatsch, Konrad Reinhart, Markus Loeffler, Christiane Hartog

Date Published: 2008

Publication Type: Journal article

Human Diseases: disease by infectious agent

Acute renal failure in patients with severe sepsis and septic shock–a significant independent risk factor for mortality: results from the German Prevalence Study
SepNet - German Competence Network Sepsis

Abstract (Expand)

BACKGROUND Sound data about the prevalence of acute renal failure (ARF) among patients with severe sepsis and septic shock are lacking. Further, it is not known whether ARF is an independent risk factor …r for mortality in septic patients or merely an indicator of disease severity. METHODS A prospective cross-sectional one-day prevalence study was carried out in a representative sample of German ICUs, divided into five strata (\textless 200 beds; 201-400 beds; 401-600 beds; \textgreater 600 beds; university hospitals). 3877 patients were screened of whom 415 had severe sepsis and septic shock. RESULTS Fourteen patients (3.4%) had chronic dialysis-dependent RF and were excluded from analysis. Of the remaining 401 patients, 166 (41.4%) had ARF, as defined by a rise in creatinine above twice the upper limit of normal and/or a drop in urine output to \textless 0.5 ml/kg bodyweight. Median APACHE II score was 22 in patients with ARF and 16 in patients without ARF (p\textless 0.0001). Patients with severe sepsis/septic shock had an overall hospital mortality of 55.2%. Hospital mortality in patients with ARF was 67.3% and without ARF 42.8% (p\textless 0.0001). After adjustment for APACHE II score and age, ARF remained a significant independent risk factor for death [odds ratio (OR) 2.11, 95% confidence interval (CI) 1.27-3.52]. Mortality in septic patients was not associated with pre-existing, non-dialysis-dependent chronic kidney disease, whereas in dialysis-dependent patients with sepsis mortality increased to 86%. CONCLUSION In this representative survey in patients with severe sepsis/septic shock, prevalence of ARF is high with 41.4%. ARF represents a significant independent risk factor for mortality in these patients.

Authors: Michael Oppert, Christoph Engel, Frank-Martin Brunkhorst, Holger Bogatsch, Konrad Reinhart, Ulrich Frei, Kai-Uwe Eckardt, Markus Loeffler, Stefan John

Date Published: 15th Oct 2007

Publication Type: Journal article

Human Diseases: disease by infectious agent

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