Personalized Swiss Sepsis Study (PSSS_digital)

February 28, 2025 updated by: University Hospital, Basel, Switzerland

Personalized Swiss Sepsis Study: With Machine Learning and Computational Modelling Towards Personalized Sepsis Management - Discovery of Digital Biomarkers

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Clinical Microbiology, University Hospital Basel
        • Contact:
      • Basel, Switzerland, 4031
        • Recruiting
        • Infectious Diseases and Hospital Epidemiology, University Hospital Basel
        • Contact:
          • Manuel Battegay, Prof Dr med
      • Basel, Switzerland, 4031
        • Recruiting
        • Medical Intensive Care Unit; University Hospital Basel
        • Contact:
          • Stephan Marsch, Prof. Dr. MD
      • Basel, Switzerland, 4031
        • Recruiting
        • Surgical Intensive Care Unit, University Hospital Basel
        • Contact:
          • Martin Siegemund, Prof. Dr. MD
      • Bern, Switzerland, 3001
        • Recruiting
        • Institute for Infectious Diseases, University of Bern
        • Contact:
          • Stephen Leib, Prof. Dr. MD
      • Bern, Switzerland, 3010
        • Recruiting
        • Division Infectious Diseases, University Hospital Bern
        • Contact:
          • Hansjakob Furrer, Prof.Dr.med
      • Bern, Switzerland, 3010
        • Recruiting
        • Intensive Care Medicine, University Hospital Bern
        • Contact:
          • Stephan Jakob, Prof. Dr. MD
      • Geneva, Switzerland, 1205
        • Recruiting
        • Division Bacteriology Laboratory, University Hospital Geneva
        • Contact:
          • Jacques Schrenzel, Prof Dr med
      • Geneva, Switzerland, 1205
        • Recruiting
        • Division Infectious Diseases, University Hospital Geneva
        • Contact:
          • Laurent Kaiser, Prof. Dr. MD
      • Geneva, Switzerland, 1205
        • Recruiting
        • Intensive Care Medicine, University Hospital Geneva
        • Contact:
          • Jérôme Pugin, Prof. Dr. MD
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Division Intensive Care Medicine, University Hospital Lausanne
        • Contact:
          • Philippe Eckert, Prof. Dr. MD
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Institute of Microbiology, University Hospital Lausanne
        • Contact:
          • Gilbert Greub, Prof. Dr. MD
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Service Infectious Diseases, University Hospital Lausanne
        • Contact:
          • Thierry Calandra, Prof. Dr. MD
      • Zürich, Switzerland, 8006
        • Not yet recruiting
        • Institute for Medical Microbiology, University Hospital Zurich
        • Contact:
          • Reinhard Zbinden, Prof. Dr. MD
      • Zürich, Switzerland, 8091
        • Not yet recruiting
        • Division Infectious Diseases, University Hospital Zurich
        • Contact:
          • Annelies Zinkernagel, Prof. Dr. MD
      • Zürich, Switzerland, 8091
        • Not yet recruiting
        • Institute for Intensive Medicine, University Hospital Zurich
        • Contact:
          • Reto Schüpbach, Prof. Dr. MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

ICU patients on a Swiss University Hospital ICU from 01.08.2019

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients with sepsis (cases)
patients who developed or were admitted with sepsis to the ICU (cases)
Other: 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
Other: 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
patients without sepsis (controls)
patients who did not develop sepsis (controls).
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
sepsis-related mortality (sensitivity)
Time Frame: 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)
time- series data collected from hospital entry until maximum 12 months after hospital exit (no exact time point specified)
sepsis-related mortality (specificity)
Time Frame: 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)
time- series data collected from hospital entry until maximum 12 months after hospital exit (no exact time point specified)
Determination of sepsis
Time Frame: 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)
time- series data collected from hospital entry until hospital exit; an average of 1 month (no exact time point specified)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss Personalized Health Network (SPHN)
Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adrian Egli, PD Dr., Clinical Microbiology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-01088; qu18Egli2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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