Status:
COMPLETED
Next-Generation Sequencing Diagnostics of Bacteremia in Sepsis
Lead Sponsor:
University Hospital Heidelberg
Collaborating Sponsors:
Fraunhofer Institute for Interfacial Engineering and Biotechnology
Dietmar Hopp Stiftung GmbH
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18-99 years
Brief Summary
Sepsis remains a major challenge, even in modern intensive care medicine. The identification of the causative pathogen is crucial for an early optimization of the antimicrobial treatment regime in pat...
Detailed Description
Sepsis remains a major challenge, even in modern intensive care medicine. The identification of the causative pathogen is crucial for an early optimization of the antimicrobial treatment regime in pat...
Eligibility Criteria
Inclusion
- 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
- Age ≤18yr
- Refusal to give consent
- Patient will probably be discharged from the ICU within the first 72h 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03356249
Start Date
March 1 2019
End Date
September 30 2021
Last Update
May 18 2022
Active Locations (21)
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1
RWTH Aachen University
Aachen, Germany, 52074
2
Klinikum Mittelbaden Baden-Baden Balg
Baden-Baden, Germany, 76532
3
Charité - Universitätsmedizin Berlin
Berlin, Germany
4
Evangelisches Krankenhaus Bethel gGmbH
Bielefeld, Germany, 33617