Personalized Swiss Sepsis Study
PSSS_digital
1 other identifier
observational
17,500
1 country
16
Brief Summary
This multi-center study is to focus on patients with sepsis in Intensive Care Units (ICUs) in order to better understand the complex host-pathogen interaction and clinical heterogeneity associated with sepsis. Understanding this heterogeneity may allow the development of novel diagnostic approaches. Data from patients will be analyzed using state-of-the art analytical algorithms for biomarker discovery including machine learning and multidimensional mathematical modelling to explore the large datasets generated. In order to discover digital biomarkers for the study endpoints a case-control study design will be used to compare data patterns from patients with sepsis (cases) and those without sepsis (controls).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2019
CompletedFirst Posted
Study publicly available on registry
October 17, 2019
CompletedStudy Start
First participant enrolled
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 5, 2025
February 1, 2025
2.5 years
October 15, 2019
February 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
sepsis-related mortality (sensitivity)
Algorithm to predict sepsis-related mortality (sensitivity)
time- series data collected from hospital entry until maximum 12 months after hospital exit (no exact time point specified)
sepsis-related mortality (specificity)
Algorithm to predict sepsis-related mortality (specificity)
time- series data collected from hospital entry until maximum 12 months after hospital exit (no exact time point specified)
Determination of sepsis
Algorithm to determine sepsis at an early stage (at least 12 hours before classical definitions)
time- series data collected from hospital entry until hospital exit; an average of 1 month (no exact time point specified)
Study Arms (2)
patients with sepsis (cases)
patients who developed or were admitted with sepsis to the ICU (cases)
patients without sepsis (controls)
patients who did not develop sepsis (controls).
Interventions
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to reliably determine sepsis
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to to predict sepsis-related mortality
Eligibility Criteria
ICU patients on a Swiss University Hospital ICU from 01.08.2019
You may qualify if:
- Patients admitted to an ICU on a Swiss University Hospital.
- Patients expected to stay at least 24h on the ICU
- Present at admission to ICU or subsequent development of sepsis 3.0 criteria
- Patients not fulfilling sepsis definition during the ICU stay
You may not qualify if:
- Decline of general consent or any other negative statement against using data for research.
- Patients with a clear elective stay on the ICUs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Clinical Microbiology, University Hospital Basel
Basel, 4031, Switzerland
Infectious Diseases and Hospital Epidemiology, University Hospital Basel
Basel, 4031, Switzerland
Medical Intensive Care Unit; University Hospital Basel
Basel, 4031, Switzerland
Surgical Intensive Care Unit, University Hospital Basel
Basel, 4031, Switzerland
Institute for Infectious Diseases, University of Bern
Bern, 3001, Switzerland
Division Infectious Diseases, University Hospital Bern
Bern, 3010, Switzerland
Intensive Care Medicine, University Hospital Bern
Bern, 3010, Switzerland
Division Bacteriology Laboratory, University Hospital Geneva
Geneva, 1205, Switzerland
Division Infectious Diseases, University Hospital Geneva
Geneva, 1205, Switzerland
Intensive Care Medicine, University Hospital Geneva
Geneva, 1205, Switzerland
Division Intensive Care Medicine, University Hospital Lausanne
Lausanne, 1011, Switzerland
Institute of Microbiology, University Hospital Lausanne
Lausanne, 1011, Switzerland
Service Infectious Diseases, University Hospital Lausanne
Lausanne, 1011, Switzerland
Institute for Medical Microbiology, University Hospital Zurich
Zurich, 8006, Switzerland
Division Infectious Diseases, University Hospital Zurich
Zurich, 8091, Switzerland
Institute for Intensive Medicine, University Hospital Zurich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian Egli, PD Dr.
Clinical Microbiology, University Hospital Basel
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2019
First Posted
October 17, 2019
Study Start
November 15, 2019
Primary Completion
May 31, 2022
Study Completion
December 1, 2025
Last Updated
March 5, 2025
Record last verified: 2025-02