Clinical trial NCT04130789: Personalized Swiss Sepsis Study
Official title: Personalized Swiss Sepsis Study: With Machine Learning and Computational Modelling Towards Personalized Sepsis Management - Discovery of Digital Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Keywords: clinical data warehouse (CDWH)
machine learning
data-driven algorithms
multi-dimensional modelling
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Personalized Health Network (SPHN)
name: Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich
First posted: 2019-10-17
Enrollment: 17500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients on a Swiss University Hospital ICU from 01.08.2019

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).


Eligibility criteria: Inclusion Criteria:

* Patients admitted to an ICU on a Swiss University Hospital.
* Patients expected to stay at least 24h on the ICU

Inclusion Criteria (cases)

* Present at admission to ICU or subsequent development of sepsis 3.0 criteria

Inclusion Criteria (controls)

* Patients not fulfilling sepsis definition during the ICU stay

Exclusion Criteria:

* Decline of general consent or any other negative statement against using data for research.
* Patients with a clear elective stay on the ICUs.

Primary outcomes:
measure: sepsis-related mortality (sensitivity)
timeFrame: time- series data collected from hospital entry until maximum 12 months after hospital exit (no exact time point specified)
measure: sepsis-related mortality (specificity)
timeFrame: time- series data collected from hospital entry until maximum 12 months after hospital exit (no exact time point specified)
measure: Determination of sepsis
timeFrame: time- series data collected from hospital entry until hospital exit; an average of 1 month (no exact time point specified)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinical Microbiology, University Hospital Basel
city: Basel
country: Switzerland
facility: Infectious Diseases and Hospital Epidemiology, University Hospital Basel
city: Basel
country: Switzerland
facility: Medical Intensive Care Unit; University Hospital Basel
city: Basel
country: Switzerland
facility: Surgical Intensive Care Unit, University Hospital Basel
city: Bern
country: Switzerland
facility: Institute for Infectious Diseases, University of Bern
city: Bern
country: Switzerland
facility: Division Infectious Diseases, University Hospital Bern
city: Bern
country: Switzerland
facility: Intensive Care Medicine, University Hospital Bern
city: Geneva
country: Switzerland
facility: Division Bacteriology Laboratory, University Hospital Geneva
city: Geneva
country: Switzerland
facility: Division Infectious Diseases, University Hospital Geneva
city: Geneva
country: Switzerland
facility: Intensive Care Medicine, University Hospital Geneva
city: Lausanne
country: Switzerland
facility: Division Intensive Care Medicine, University Hospital Lausanne
city: Lausanne
country: Switzerland
facility: Institute of Microbiology, University Hospital Lausanne
city: Lausanne
country: Switzerland
facility: Service Infectious Diseases, University Hospital Lausanne
city: Zürich
country: Switzerland
facility: Institute for Medical Microbiology, University Hospital Zurich
city: Zürich
country: Switzerland
facility: Division Infectious Diseases, University Hospital Zurich
city: Zürich
country: Switzerland
facility: Institute for Intensive Medicine, University Hospital Zurich
Study officials:
affiliation: Clinical Microbiology, University Hospital Basel
name: Adrian Egli, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: