Personalized Swiss Sepsis Study

NCT04130789 · tracked via the Priya Life Science Switzerland tracker

Sponsor

University Hospital, Basel, Switzerland

Phase

Observational

Started

2019-11-15

Last updated

2025-03-05

Condition(s) studied

Sepsis

Investigational drug(s) / intervention(s)

compare data patterns by data-driven algorithms to determine sepsiscompare data patterns by data-driven algorithms to predict sepsis-related mortality

compare data patterns by data-driven algorithms to determine sepsis: 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 to predict sepsis-related mortality: compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to to predict sepsis-related mortality

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

sepsis-related mortality (sensitivity) — time- series data collected from hospital entry until maximum 12 months after hospital exit (no exact time point specified)
Algorithm to predict sepsis-related mortality (sensitivity)
sepsis-related mortality (specificity) — time- series data collected from hospital entry until maximum 12 months after hospital exit (no exact time point specified)
Algorithm to predict sepsis-related mortality (specificity)
Determination of sepsis — time- series data collected from hospital entry until hospital exit; an average of 1 month (no exact time point specified)
Algorithm to determine sepsis at an early stage (at least 12 hours before classical definitions)

Trial sites (16)

Facility	City	Region	Status
Clinical Microbiology, University Hospital Basel	Basel	Switzerland	Recruiting
Infectious Diseases and Hospital Epidemiology, University Hospital Basel	Basel	Switzerland	Recruiting
Medical Intensive Care Unit; University Hospital Basel	Basel	Switzerland	Recruiting
Surgical Intensive Care Unit, University Hospital Basel	Basel	Switzerland	Recruiting
Institute for Infectious Diseases, University of Bern	Bern	Switzerland	Recruiting
Division Infectious Diseases, University Hospital Bern	Bern	Switzerland	Recruiting
Intensive Care Medicine, University Hospital Bern	Bern	Switzerland	Recruiting
Division Bacteriology Laboratory, University Hospital Geneva	Geneva	Switzerland	Recruiting
Division Infectious Diseases, University Hospital Geneva	Geneva	Switzerland	Recruiting
Intensive Care Medicine, University Hospital Geneva	Geneva	Switzerland	Recruiting
Division Intensive Care Medicine, University Hospital Lausanne	Lausanne	Switzerland	Recruiting
Institute of Microbiology, University Hospital Lausanne	Lausanne	Switzerland	Recruiting
Service Infectious Diseases, University Hospital Lausanne	Lausanne	Switzerland	Recruiting
Institute for Medical Microbiology, University Hospital Zurich	Zurich	Switzerland	Not Yet Recruiting
Division Infectious Diseases, University Hospital Zurich	Zurich	Switzerland	Not Yet Recruiting
Institute for Intensive Medicine, University Hospital Zurich	Zurich	Switzerland	Not Yet Recruiting

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Other trials for the same condition

Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis Starting soon

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04130789 on ClinicalTrials.gov ↗ ← All trials in Switzerland