PSSS_digital: Personalized Swiss Sepsis Study

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04130789
• Collaborator: Swiss Personalized Health Network (SPHN) (Other), Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich (Other)
• Enrollment: 17,500
• Locations: 16
• Anticipated Duration (Months): 42.5
• Patients Per Site: 1093.8
• Patients Per Site Per Month: 25.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Other: compare data patterns by data-driven algorithms to determine sepsis; Other: compare data patterns by data-driven algorithms to predict sepsis-related mortality

Study Design

• Study Type: Observational
• Anticipated Enrollment: 17500 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Personalized Swiss Sepsis Study: With Machine Learning and Computational Modelling Towards Personalized Sepsis Management - Discovery of Digital Biomarkers
• Actual Study Start Date: Nov 15, 2019
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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)

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Microbiology, University Hospital Basel	Basel		Switzerland	4031
2	Infectious Diseases and Hospital Epidemiology, University Hospital Basel	Basel		Switzerland	4031
3	Medical Intensive Care Unit; University Hospital Basel	Basel		Switzerland	4031
4	Surgical Intensive Care Unit, University Hospital Basel	Basel		Switzerland	4031
5	Institute for Infectious Diseases, University of Bern	Bern		Switzerland	3001
6	Division Infectious Diseases, University Hospital Bern	Bern		Switzerland	3010
7	Intensive Care Medicine, University Hospital Bern	Bern		Switzerland	3010
8	Division Bacteriology Laboratory, University Hospital Geneva	Geneva		Switzerland	1205
9	Division Infectious Diseases, University Hospital Geneva	Geneva		Switzerland	1205
10	Intensive Care Medicine, University Hospital Geneva	Geneva		Switzerland	1205
11	Division Intensive Care Medicine, University Hospital Lausanne	Lausanne		Switzerland	1011
12	Institute of Microbiology, University Hospital Lausanne	Lausanne		Switzerland	1011
13	Service Infectious Diseases, University Hospital Lausanne	Lausanne		Switzerland	1011
14	Institute for Medical Microbiology, University Hospital Zurich	Zürich		Switzerland	8006
15	Division Infectious Diseases, University Hospital Zurich	Zürich		Switzerland	8091
16	Institute for Intensive Medicine, University Hospital Zurich	Zürich		Switzerland	8091

Sponsors and Collaborators

• University Hospital, Basel, Switzerland
• Swiss Personalized Health Network (SPHN)
• Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich

Investigators

• Principal Investigator: Adrian Egli, PD Dr., Clinical Microbiology, University Hospital Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT04130789
• Other Study ID Numbers: 2018-01088; qu18Egli2
• First Posted: Oct 17, 2019
• Last Update Posted: Aug 4, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: clinical data warehouse (CDWH); machine learning; data-driven algorithms; multi-dimensional modelling
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Aug 4, 2021