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 Reportar como inadecuado




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 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Infectious Diseases

, 8:91

First Online: 13 July 2008Received: 06 June 2008Accepted: 13 July 2008

Abstract

BackgroundSepsis 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.

MethodsMulti-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.

DiscussionFor 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.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2334-8-91 contains supplementary material, which is available to authorized users.

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Autor: Jens-Ulrik Jensen - Bettina Lundgren - Lars Hein - Thomas Mohr - Pernille L Petersen - Lasse H Andersen - Anne Ø Laurit

Fuente: https://link.springer.com/







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