The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitoninand pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population): 1000 patients

Jensen, Jens‐Ulrik Stæhr; Lundgren, Bettina; Hein, Lars; Mohr, Thomas; Petersen, Pernille Lykke; Andersen, Lasse H.; Lauritsen, Anne Øberg; Hougaard, Sine; Mantoni, Teit; Bømler, Bonnie Kathrine; Thornberg, Klaus J.; Þormar, Katrín; Løken, Jesper; Steensen, Morten; Carl, P; Petersen, John Asger; Tousi, Hamid; Søe‐Jensen, Peter; Bestle, Morten H.; Hestad, Søren; Andersen, Mads; Fjeldborg, Paul; Larsen, K. Kyllesbech; Rossau, Charlotte Dahl; Thomsen, Carsten B; Østergaard, Christian Richter; Kjær, Jesper; Grarup, Jesper; Lundgren, Jens D

doi:10.1186/1471-2334-8-91

Cited by 38 publications

(22 citation statements)

References 10 publications

(9 reference statements)

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“…A robust evidence-based approach to studying PCT in clinical care is currently lacking, as demonstrated by the grade 2C recommendation in the recent Surviving Sepsis Campaign guidelines (23). Two previous large clinical trials reported that measurement of serial PCT values resulted in fewer overall antibiotic days without a difference in number of deaths (13,24). More recently, the Stop Antibiotics on Guidance of Prolactin Study (SAPS) confirmed that measuring PCT can help reduce the duration of antibiotic therapy, and this reduction is associated with a significant decrease in mortality (25).…”

Section: Discussionmentioning

confidence: 99%

Determining the Clinical Utility of an Absolute Procalcitonin Value for Predicting a Positive Culture Result

Caffarini

DeMott

Patel

et al. 2017

Antimicrob Agents Chemother

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Various procalcitonin ranges have been established to guide antimicrobial therapy; however, there are no data that establish whether the initial procalcitonin value can determine the likelihood of a positive culture result. This study aimed to establish if the initial procalcitonin value, on clinical presentation, has a positive predictive value for any positive culture result. This was a retrospective study of 813 medical intensive care unit patients. Data collected included patient demographics, procalcitonin assay results, sources of infection, culture results, and lengths of stay. Patients were excluded if they were immunocompromised. The primary outcome of this study was to determine a procalcitonin value that would predict any positive culture. Secondary outcomes included the sensitivity, specificity, positive predictive value, and negative predictive value for procalcitonin. After exclusions, a total of 519 patient charts were reviewed to determine the impact of the initial procalcitonin value on culture positivity. In our analyses, the receiver operating characteristic values were 0.62 for all cultures, 0.49 for pulmonary infections, 0.43 for urinary tract infections, and 0.78 for bacteremia. A procalcitonin value of 3.61 ng/ml was determined to be the threshold value for a positive blood culture result (prevalence, 4%). For bacteremia, the sensitivity of procalcitonin was 75%, the specificity was 72%, the positive predictive value was 20%, and the negative predictive value was 97%. Procalcitonin was a poor predictor of culture positivity. An initial procalcitonin value of less than 3.61 ng/ml may be useful in predicting whether bacteremia is absent. Procalcitonin should not be used as the only predictor for determining initiation of antibiotic therapy.KEYWORDS biomarkers, diagnostics, procalcitonin, sepsis S epsis is a leading cause of death and disability in the United States (1, 2). Mortality from sepsis increases with each hour that anti-infective therapy is delayed (3). The impetus for promptly initiating appropriate broad-spectrum antimicrobial therapy must be weighed against the concern for reducing unnecessary antimicrobial therapy and potential harms, such as drug resistance, Clostridium difficile infections, and adverse drug effects (3). The lack of a specific test to assist clinicians in early decision-making regarding initiation and discontinuation of antimicrobial therapy for severe infection and presumed sepsis has led to expanded interest in inflammatory biomarkers, such as procalcitonin (PCT) (4-12).Previous trials evaluating PCT have used value ranges to guide clinical decisions within the construct of initiating and discontinuing antimicrobial therapy using clinical criteria (4,5,(7)(8)(9)(10)(12)(13)(14). By using serial measurements and established cutoff values in intensive care units (ICUs), these studies have shown that PCT values guide antimicrobial therapy (13-18). However, no reports have described the utility of using initial PCT levels to guide upstream anti-infective...

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Section: Discussionmentioning

confidence: 99%

Determining the Clinical Utility of an Absolute Procalcitonin Value for Predicting a Positive Culture Result

Caffarini

DeMott

Patel

et al. 2017

Antimicrob Agents Chemother

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“…Monitoring PCT levels is readily available with a commercial immunoluminometric test and for this reason it is a very attractive biomarker, but more studies are needed to prove its utility in monitoring of immunological disturbances. However, the utility of monitoring PCT concentration in sepsis patients has been proved in several randomized clinical trials (Bouadma et al 2010;Hochreiter et al 2009;Jensen et al 2008Jensen et al , 2011Nobre et al 2008;Schroeder et al 2009;Stocker et al 2010). It allows to optimize and reduce antibiotic use in these patients which contributes to the prevention of selection of drug-resistant pathogens.…”

Section: Procalcitoninmentioning

confidence: 99%

Sepsis Immunopathology: Perspectives of Monitoring and Modulation of the Immune Disturbances

Skirecki

Borkowska-Zielińska

Złotorowicz

et al. 2012

Arch. Immunol. Ther. Exp.

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Septic syndromes are the main cause of death in the intensive care units and although the mortality rates is slowly decreasing, the occurrence of the disease has been increasing. The pathogenesis of sepsis includes countless disturbances of the host immune system starting with a harmful, infection-triggered exaggerated inflammatory cascade, followed by the development of an immunoparalysis state. The latter contributes to the failure in pathogen eradication and leads to secondary infections, which are often the cause of fatal complications. In this review, we consider different novel therapeutic strategies for restoration of immune function. The use of glucocorticoids, intravenous immunoglobulins, heparin, recombinant human activated protein C, granulocyte macrophage colony-stimulating factor, granulocyte colony-stimulating factor, interferon-γ, statins, macrolides and high-volume hemofiltration are discussed. Even though some clinical trials of these regimens are promising, the key to their successful application seems to be the precise monitoring of the status of immune system followed by implementation of the adequate therapy. Thus, in this paper we present disturbances in the immune system in the course of human sepsis, with special attention to the parameters that could be monitored and serve as markers for immunomodulatory therapies. We conclude by briefly presenting the current sepsis treatment strategy.

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“…Es konnte keine Reduktion der Mortalität in der PCT-Gruppe belegt werden, jedoch wurde ein prolongierter Verlauf der Atemwegserkrankungen in der PCT-Gruppe beobachtet. Das bereits 2008 veröffentlichte Studienprotokoll weist deutliche Unterschiede zu den PCT-Algorithmen der bisher diskutierten Arbeitsgruppen auf [70]. So sah das Protokoll der dänischen Arbeitsgruppe vor, die Antibio tikatherapie zu beenden, wenn der PCT-Wert >1 ng/ml und über 3 Tage jeweils um 10% gesunken war.…”

Section: Steuerung Einer Antibiotikatherapieunclassified

Prokalzitoninbasierte Algorithmen

Hochreiter

Schroeder

2011

Anaesthesist

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Sepsis is one of the most cost-intensive conditions of critically ill patients in intensive care medicine. Furthermore, sepsis is known to be the leading cause of morbidity and of mortality in intensive care patients. Early initiation of antibiotic therapy can significantly reduce mortality. The development of resistance of bacterial species against antibiotics is a compelling issue to reconsider indications and administration of antibiotic treatment. Adequate indications and duration of therapy are particularly important for the use of highly potent substances in the intensive care setting. Until recently no laboratory marker has been available to distinguish bacterial infections from viral or non-infectious inflammatory responses. However, procalcitonin (PCT) appears to be the first among a large array of inflammatory markers that offers this possibility. Regular procalcitonin measurements can significantly shorten the length of antibiotic therapy, show positive influence on antibiotic costs and have no adverse affects on patient outcome.

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Cited by 38 publications

References 10 publications

Determining the Clinical Utility of an Absolute Procalcitonin Value for Predicting a Positive Culture Result

Determining the Clinical Utility of an Absolute Procalcitonin Value for Predicting a Positive Culture Result

Sepsis Immunopathology: Perspectives of Monitoring and Modulation of the Immune Disturbances

Prokalzitoninbasierte Algorithmen

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