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The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and 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

BACKGROUND: Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. The infectious status of the critically ill patient is often difficult to assess because symptoms cannot be expressed...

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Autores principales: Jensen, Jens-Ulrik, Lundgren, Bettina, Hein, Lars, Mohr, Thomas, Petersen, Pernille L, Andersen, Lasse H, Lauritsen, Anne Ø, Hougaard, Sine, Mantoni, Teit, Bømler, Bonnie, Thornberg, Klaus J, Thormar, Katrin, Løken, Jesper, Steensen, Morten, Carl, Peder, Petersen, J Asger, Tousi, Hamid, Søe-Jensen, Peter, Bestle, Morten, Hestad, Søren, Andersen, Mads H, Fjeldborg, Paul, Larsen, Kim M, Rossau, Charlotte, Thomsen, Carsten B, Østergaard, Christian, Kjær, Jesper, Grarup, Jesper, Lundgren, Jens D
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2008
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2491622/
https://www.ncbi.nlm.nih.gov/pubmed/18620598
http://dx.doi.org/10.1186/1471-2334-8-91
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author Jensen, Jens-Ulrik
Lundgren, Bettina
Hein, Lars
Mohr, Thomas
Petersen, Pernille L
Andersen, Lasse H
Lauritsen, Anne Ø
Hougaard, Sine
Mantoni, Teit
Bømler, Bonnie
Thornberg, Klaus J
Thormar, Katrin
Løken, Jesper
Steensen, Morten
Carl, Peder
Petersen, J Asger
Tousi, Hamid
Søe-Jensen, Peter
Bestle, Morten
Hestad, Søren
Andersen, Mads H
Fjeldborg, Paul
Larsen, Kim M
Rossau, Charlotte
Thomsen, Carsten B
Østergaard, Christian
Kjær, Jesper
Grarup, Jesper
Lundgren, Jens D
author_facet Jensen, Jens-Ulrik
Lundgren, Bettina
Hein, Lars
Mohr, Thomas
Petersen, Pernille L
Andersen, Lasse H
Lauritsen, Anne Ø
Hougaard, Sine
Mantoni, Teit
Bømler, Bonnie
Thornberg, Klaus J
Thormar, Katrin
Løken, Jesper
Steensen, Morten
Carl, Peder
Petersen, J Asger
Tousi, Hamid
Søe-Jensen, Peter
Bestle, Morten
Hestad, Søren
Andersen, Mads H
Fjeldborg, Paul
Larsen, Kim M
Rossau, Charlotte
Thomsen, Carsten B
Østergaard, Christian
Kjær, Jesper
Grarup, Jesper
Lundgren, Jens D
author_sort Jensen, Jens-Ulrik
collection PubMed
description BACKGROUND: Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. The infectious status of the critically ill patient is often difficult to assess because symptoms cannot be expressed and signs may present atypically. The established biological markers of inflammation (leucocytes, C-reactive protein) may often be influenced by other parameters than infection, and may be unacceptably slowly released after progression of an infection. At the same time, lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient. Specific and rapid markers of bacterial infection have been sought for use in these patients. METHODS: Multi-centre randomized controlled interventional trial. Powered for superiority and non-inferiority on all measured end points. Complies with, "Good Clinical Practice" (ICH-GCP Guideline (CPMP/ICH/135/95, Directive 2001/20/EC)). Inclusion: 1) Age ≥ 18 years of age, 2) Admitted to the participating intensive care units, 3) Signed written informed consent. Exclusion: 1) Known hyper-bilirubinaemia. or hypertriglyceridaemia, 2) Likely that safety is compromised by blood sampling, 3) Pregnant or breast feeding. Computerized Randomisation: Two arms (1:1), n = 500 per arm: Arm 1: standard of care. Arm 2: standard of care and Procalcitonin guided diagnostics and treatment of infection. Primary Trial Objective: To address whether daily Procalcitonin measurements and immediate diagnostic and therapeutic response on day-to-day changes in procalcitonin can reduce the mortality of critically ill patients. DISCUSSION: For the first time ever, a mortality-endpoint, large scale randomized controlled trial with a biomarker-guided strategy compared to the best standard of care, is conducted in an Intensive care setting. Results will, with a high statistical power answer the question: Can the survival of critically ill patients be improved by actively using biomarker procalcitonin in the treatment of infections? 700 critically ill patients are currently included of 1000 planned (June 2008). Two interim analyses have been passed without any safety or futility issues, and the third interim analysis is soon to take place. Trial registration number at clinicaltrials.gov: Id. nr.: NCT00271752).
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spelling pubmed-24916222008-07-31 The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and 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 Lundgren, Bettina Hein, Lars Mohr, Thomas Petersen, Pernille L Andersen, Lasse H Lauritsen, Anne Ø Hougaard, Sine Mantoni, Teit Bømler, Bonnie Thornberg, Klaus J Thormar, Katrin Løken, Jesper Steensen, Morten Carl, Peder Petersen, J Asger Tousi, Hamid Søe-Jensen, Peter Bestle, Morten Hestad, Søren Andersen, Mads H Fjeldborg, Paul Larsen, Kim M Rossau, Charlotte Thomsen, Carsten B Østergaard, Christian Kjær, Jesper Grarup, Jesper Lundgren, Jens D BMC Infect Dis Study Protocol BACKGROUND: Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. The infectious status of the critically ill patient is often difficult to assess because symptoms cannot be expressed and signs may present atypically. The established biological markers of inflammation (leucocytes, C-reactive protein) may often be influenced by other parameters than infection, and may be unacceptably slowly released after progression of an infection. At the same time, lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient. Specific and rapid markers of bacterial infection have been sought for use in these patients. METHODS: Multi-centre randomized controlled interventional trial. Powered for superiority and non-inferiority on all measured end points. Complies with, "Good Clinical Practice" (ICH-GCP Guideline (CPMP/ICH/135/95, Directive 2001/20/EC)). Inclusion: 1) Age ≥ 18 years of age, 2) Admitted to the participating intensive care units, 3) Signed written informed consent. Exclusion: 1) Known hyper-bilirubinaemia. or hypertriglyceridaemia, 2) Likely that safety is compromised by blood sampling, 3) Pregnant or breast feeding. Computerized Randomisation: Two arms (1:1), n = 500 per arm: Arm 1: standard of care. Arm 2: standard of care and Procalcitonin guided diagnostics and treatment of infection. Primary Trial Objective: To address whether daily Procalcitonin measurements and immediate diagnostic and therapeutic response on day-to-day changes in procalcitonin can reduce the mortality of critically ill patients. DISCUSSION: For the first time ever, a mortality-endpoint, large scale randomized controlled trial with a biomarker-guided strategy compared to the best standard of care, is conducted in an Intensive care setting. Results will, with a high statistical power answer the question: Can the survival of critically ill patients be improved by actively using biomarker procalcitonin in the treatment of infections? 700 critically ill patients are currently included of 1000 planned (June 2008). Two interim analyses have been passed without any safety or futility issues, and the third interim analysis is soon to take place. Trial registration number at clinicaltrials.gov: Id. nr.: NCT00271752). BioMed Central 2008-07-13 /pmc/articles/PMC2491622/ /pubmed/18620598 http://dx.doi.org/10.1186/1471-2334-8-91 Text en Copyright © 2008 Jensen et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Jensen, Jens-Ulrik
Lundgren, Bettina
Hein, Lars
Mohr, Thomas
Petersen, Pernille L
Andersen, Lasse H
Lauritsen, Anne Ø
Hougaard, Sine
Mantoni, Teit
Bømler, Bonnie
Thornberg, Klaus J
Thormar, Katrin
Løken, Jesper
Steensen, Morten
Carl, Peder
Petersen, J Asger
Tousi, Hamid
Søe-Jensen, Peter
Bestle, Morten
Hestad, Søren
Andersen, Mads H
Fjeldborg, Paul
Larsen, Kim M
Rossau, Charlotte
Thomsen, Carsten B
Østergaard, Christian
Kjær, Jesper
Grarup, Jesper
Lundgren, Jens D
The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and 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
title The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and 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
title_full The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and 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
title_fullStr The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and 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
title_full_unstemmed The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and 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
title_short The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and 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
title_sort procalcitonin and survival study (pass) – a randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker procalcitonin and 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2491622/
https://www.ncbi.nlm.nih.gov/pubmed/18620598
http://dx.doi.org/10.1186/1471-2334-8-91
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