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Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care in Turkey

Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care in Turkey

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04304456
Enrollment
810
Registered
2020-03-11
Start date
2020-06-30
Completion date
2022-04-30
Last updated
2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Hospital Acquired Condition, Sepsis

Keywords

Bacteremia, Antimicrobial resistance, Mortality, Hospital acquired infections

Brief summary

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.

Detailed description

Blood stream infection (BSI) is defined as the identification of a culprit pathogen in the blood culture sample of a participant. As such, and once contaminants are excluded, BSI is the only cause of sepsis where the presence of an infection and the pathogen are known with certainty. This makes BSI the perfect model of infection to study the effects of the micro-organism on the participant, and the effects of the antibiotics and other treatments on survival. There is an increasing trend in antimicrobial resistance rates among microorganisms that are associated with nosocomial infections treated in ICU. However, infectious diseases physicians from Turkey do not know contemporary epidemiological data of hospital-acquired BSI treated in ICU in Turkey. This study 'Epidemiology and Determinants of Outcomes of Hospital-Acquired Blood Stream Infections in the Intensive Care in Turkey' is a multi-center prospective observational cohort study that will include patients with hospital-acquired blood stream infections (HA-BSI) treated in ICUs in Turkey. This study will present unknown current epidemiology of HA-BSI in Turkey. Furthermore, It will provide very important data about 28-day mortality rates of HA-BSI treated in ICU. The primary outcomes of this study can be accounted as following: (i)determinants of outcomes of HA-BSI, (ii) the effects of the source of infection on outcomes, (iii) the effects of microorganism on these outcomes, (iv) the effects of antimicrobial therapy and of source control on investigated outcomes. In this study, participant specific and organizational factors will be explored and the determinants of management of HA-BSI in ICUs will be described. There will be no intervention in this study. The data of participants will be obtained from hospital database and recorded into electronic case report forms anonymously.

Interventions

OTHERTreatment

Antimicrobial and other treatment modalities such as source control, vasoactive medications, dialysis

Sponsors

European Society of Intensive Care Medicine
CollaboratorOTHER
SCARE (Study group for carbapenem resistance)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortality Rate28-day mortalityRate of all cause mortality

Secondary

MeasureTime frameDescription
Progress of organ failures7-dayAssessed by the components of the Sequential Organ Failure Assessment (SOFA) score, minimum (0 point)- Maximum (24 points)
Days free or organ supportive therapy28-dayDays free of renal replacement therapy, mechanical ventilation, vasopressors, intensive care unit
Rate of Clinical cure7-day and 28-dayAs 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.
Rate of Microbiological cure7-day and 28-dayPresence of persisting or relapsing blood stream infection

Contacts

Primary ContactAbdullah Tarık Aslan
aslanabdullahtarik@gmail.com+905346754889
Backup ContactMurat Akova
akova.murat@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026