Personalized Swiss Sepsis Study

Recruiting

• Conditions: Sepsis
• Interventions: Other: compare data patterns by data-driven algorithms to determine sepsis; Other: compare data patterns by data-driven algorithms to predict sepsis-related mortality

• Registration Number: NCT04130789
• Lead Sponsor: University Hospital, Basel, Switzerland

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-17
• Study Start: 2019-11-15
• Primary Completion: 2022-05-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients without sepsis (controls)	compare data patterns by data-driven algorithms to determine sepsis	patients who did not develop sepsis (controls).
patients without sepsis (controls)	compare data patterns by data-driven algorithms to predict sepsis-related mortality	patients who did not develop sepsis (controls).
patients with sepsis (cases)	compare data patterns by data-driven algorithms to determine sepsis	patients who developed or were admitted with sepsis to the ICU (cases)
patients with sepsis (cases)	compare data patterns by data-driven algorithms to predict sepsis-related mortality	patients who developed or were admitted with sepsis to the ICU (cases)

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (16)

Clinical Microbiology, University Hospital Basel; 🇨🇭 Basel, Switzerland

Infectious Diseases and Hospital Epidemiology, University Hospital Basel; 🇨🇭 Basel, Switzerland

Medical Intensive Care Unit; University Hospital Basel; 🇨🇭 Basel, Switzerland

Institute for Infectious Diseases, University of Bern; 🇨🇭 Bern, Switzerland

Institute of Microbiology, University Hospital Lausanne; 🇨🇭 Lausanne, Switzerland

Service Infectious Diseases, University Hospital Lausanne; 🇨🇭 Lausanne, Switzerland

Institute for Medical Microbiology, University Hospital Zurich; 🇨🇭 Zürich, Switzerland

Institute for Intensive Medicine, University Hospital Zurich; 🇨🇭 Zürich, Switzerland

Division Bacteriology Laboratory, University Hospital Geneva; 🇨🇭 Geneva, Switzerland

Intensive Care Medicine, University Hospital Bern; 🇨🇭 Bern, Switzerland

Surgical Intensive Care Unit, University Hospital Basel; 🇨🇭 Basel, Switzerland

Division Infectious Diseases, University Hospital Bern; 🇨🇭 Bern, Switzerland

Intensive Care Medicine, University Hospital Geneva; 🇨🇭 Geneva, Switzerland

Division Infectious Diseases, University Hospital Geneva; 🇨🇭 Geneva, Switzerland

Division Infectious Diseases, University Hospital Zurich; 🇨🇭 Zürich, Switzerland

Division Intensive Care Medicine, University Hospital Lausanne; 🇨🇭 Lausanne, Switzerland