Sepsis Clinical Trial
Official title:
Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care in Turkey
NCT number | NCT04304456 |
Other study ID # | KA-19126 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2020 |
Est. completion date | April 2022 |
In this observational study, it is aimed to investigate the mortality and morbidity rates of hospital-acquired blood stream infections that are treated in intensive care units (ICU). The effects of properties of the micro-organism such as type and antimicrobial resistance on the infection and its outcomes will be mainly explored. In addition, the impact of antibiotic options and other treatment modalities on survival of patients will be investigated. Twenty-seven different ICUs from Turkey will be included in this study.
Status | Not yet recruiting |
Enrollment | 810 |
Est. completion date | April 2022 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > 18 Years. - Hospital Acquired Bloodstream Infection (HA-BSI). - Treated in the ICU. - ICU acquired OR Hospital acquired prior to ICU admission Exclusion Criteria: - Patients that had a positive blood culture in the hospital and transferred to ICU for a different reason than specific treatment of the causes or consequences of HA-BSI. - Previous inclusion in the study. - HA-BSI is defined as a positive blood culture (BC) sampled after 48 hours following hospital admission. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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SCARE (Study group for carbapenem resistance) | European Society of Intensive Care Medicine |
De Waele JJ, Akova M, Antonelli M, Canton R, Carlet J, De Backer D, Dimopoulos G, Garnacho-Montero J, Kesecioglu J, Lipman J, Mer M, Paiva JA, Poljak M, Roberts JA, Rodriguez Bano J, Timsit JF, Zahar JR, Bassetti M. Antimicrobial resistance and antibiotic stewardship programs in the ICU: insistence and persistence in the fight against resistance. A position statement from ESICM/ESCMID/WAAAR round table on multi-drug resistance. Intensive Care Med. 2018 Feb;44(2):189-196. doi: 10.1007/s00134-017-5036-1. Epub 2017 Dec 29. — View Citation
PRISM Investigators, Rowan KM, Angus DC, Bailey M, Barnato AE, Bellomo R, Canter RR, Coats TJ, Delaney A, Gimbel E, Grieve RD, Harrison DA, Higgins AM, Howe B, Huang DT, Kellum JA, Mouncey PR, Music E, Peake SL, Pike F, Reade MC, Sadique MZ, Singer M, Yealy DM. Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis. N Engl J Med. 2017 Jun 8;376(23):2223-2234. doi: 10.1056/NEJMoa1701380. Epub 2017 Mar 21. — View Citation
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation
Tabah A, Koulenti D, Laupland K, Misset B, Valles J, Bruzzi de Carvalho F, Paiva JA, Cakar N, Ma X, Eggimann P, Antonelli M, Bonten MJ, Csomos A, Krueger WA, Mikstacki A, Lipman J, Depuydt P, Vesin A, Garrouste-Orgeas M, Zahar JR, Blot S, Carlet J, Brun-Buisson C, Martin C, Rello J, Dimopoulos G, Timsit JF. Characteristics and determinants of outcome of hospital-acquired bloodstream infections in intensive care units: the EUROBACT International Cohort Study. Intensive Care Med. 2012 Dec;38(12):1930-45. doi: 10.1007/s00134-012-2695-9. Epub 2012 Sep 26. — View Citation
Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality Rate | Rate of all cause mortality | 28-day mortality | |
Secondary | Progress of organ failures | Assessed by the components of the Sequential Organ Failure Assessment (SOFA) score, minimum (0 point)- Maximum (24 points) | 7-day | |
Secondary | Days free or organ supportive therapy | Days free of renal replacement therapy, mechanical ventilation, vasopressors, intensive care unit | 28-day | |
Secondary | Rate of Clinical cure | As evaluated by the treating clinician. There will be no specific tool for evaluation of clinical cure. It will be only determined by the clinical assessment of admitting physicians. | 7-day and 28-day | |
Secondary | Rate of Microbiological cure | Presence of persisting or relapsing blood stream infection | 7-day and 28-day |
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