ext-Generation Sequencing (NGS) diagnostics of bacteremia in sepsis

Conditions: R65.1
Systemic Inflammatory Response Syndrome of infectious origin with organ failure

Registration Number: DRKS00011911

Lead Sponsor: Klinik für Anästhesiologie, Universitätsklinikum Essen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 500

Inclusion Criteria

Age =18yr
- Informed consent

Sepsis (with an onset =24h)
-Patients with a life-threatening organ dysfunction caused by a dysregulated host response to a suspected or proven infection. Organ dysfunction can be identified as an acute change in total SOFA score =2 points consequent to the infection. Patients can also be promptly identified at the bedside with qSOFA, ie, alteration in mental status, systolic blood pressure =100mmHg, or respiratory rate =22/min.

or Septic shock (with an onset =24h)
-Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) =65mmHg and having a serum lactate level >2mmol/L (18mg/dL) despite adequate volume resuscitation

Exclusion Criteria

- Age =18yr
- Refusal to give consent
- Patient will probably be discharged from the ICU within the first 72 hours following inclusion
- Palliative treatment intent
- Clinician is not committed to aggressive treatment
- Death is deemed imminent and inevitable
- Patients who had previously been included, but are readmitted to the ICU during the same hospitalization, will not be included a second time.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For the evaluation of NGS-performance (sensitivity, specificity, positive predictive value, negative predictive value), results of the NGS-based approach for each sample will be compared with those obtained using conventional microbiology methods for the same sample. Moreover, interobserver agreement will be assessed by the calculation of Cohens Kappa.The clinical value of the NGS-based approach will be estimated by a panel of three independent clinical specialists not associated with the study site, retrospectively identifying potential changes in patients´ management based on NGS results.

Secondary Outcome Measures

Name	Time	Method
1.) Diagnostic or prognostic value of host nucleosome positioning patterns derived from plasma cellfree DNA in patients with suspected or proven sepsis, 2.) Diagnostic value of host expression profiles including RNA-derived biomarkers in patients with suspected or proven sepsis, 3.) Diagnostic or prognostic value of methylglyoxal (MG)-derived carbonylstress in patients with suspected or proven sepsis, 4.) Evaluation of antimicrobial resistance patterns and virulence factors, 5.) Evaluation of process times for NGS-based measurements