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

• Conditions: Bacteremia; Hospital Acquired Condition; Sepsis
• Interventions: Other: Treatment

• Registration Number: NCT04304456
• Lead Sponsor: SCARE (Study group for carbapenem resistance)

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-11
• Last Update Posted: 2020-03-11
• Study Start: 2020-06
• Primary Completion: 2021-09
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 810

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HA-BSI	Treatment	Patients with HA-BSI treated in an ICU

Primary Outcome Measures

Name	Time	Method
Mortality Rate	28-day mortality	Rate of all cause mortality

Secondary Outcome Measures

Name	Time	Method
Rate of Microbiological cure	7-day and 28-day	Presence of persisting or relapsing blood stream infection
Days free or organ supportive therapy	28-day	Days free of renal replacement therapy, mechanical ventilation, vasopressors, intensive care unit
Progress of organ failures	7-day	Assessed by the components of the Sequential Organ Failure Assessment (SOFA) score, minimum (0 point)- Maximum (24 points)
Rate of Clinical cure	7-day and 28-day	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.