Exploratory Study to Investigate the Association Between the Onset of Disseminated Intravascular Coagulation (DIC) and Disease Progression With Different Biomarker Candidates as Well as Standard Clinical and Demographic Parameters in Adult Patients With Sepsis

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is an exploratory study in which data from people with sepsis (a serious condition in which the body responds to an infection that damages vital organs) admitted to an Intensive care unit (ICU) who will receive treatment are studied. Sepsis is a serious condition that happens when the body's reaction to an infection causes organ damage. Disseminated intravascular coagulation (DIC) is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. DIC is a serious condition that can happen in people with sepsis, which may further lead to organ damage or even death. No investigational products will be administered in this study. Participants will be treated with the standard of care (SOC) for sepsis. The SOC is the treatment that medical experts consider most appropriate currently. There are limited treatments available for DIC, especially for people with sepsis and other diseases. To better understand the impact of sepsis, and how it develops into DIC, more knowledge is needed in the European population. The main purpose of this study is to learn about how sepsis worsens, especially from the time a person is admitted to the ICU until they develop DIC. To do this, researchers will identify certain biomarkers to understand how DIC develops and progresses in people with sepsis. A biomarker is present in blood, other body fluids, or tissues and indicates a disease or abnormal process inside the body. To learn about this, researchers will collect information about the participants who develop DIC, including cause, and severity of DIC (using a score called ISTH DIC Score). The data will be collected from participants' hospital records in more than three European countries. Each participant will be in the study for up to 56 days. During the study, the doctors and their study team will take blood samples up to 6 times to check for the presence of biomarkers for the identification of people with DIC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be 18 years of age inclusive, at the time of signing the informed consent.

• Participants with diagnosed sepsis according to sepsis-3 definition.

• Participants with documented suspected origin of infection.

• Informed consent of capable participant or, in case of participant being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.

Locations
Other Locations
Austria
MedUni Graz | Innere Medizin, ICU
NOT_YET_RECRUITING
Graz
MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin
RECRUITING
Innsbruck
MedUni Wien | Univ. Klinik für Klinische Pharmakologie
NOT_YET_RECRUITING
Vienna
Belgium
AZ Groeninge - Campus Kennedylaan
RECRUITING
Kortrijk
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
RECRUITING
Liège
Clinique Saint-Pierre d'Ottignies - Intensive Care
RECRUITING
Ottignies-louvain-la-neuve
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
RECRUITING
Woluwe-saint-lambert
France
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
RECRUITING
Angers
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
RECRUITING
Garches
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
RECRUITING
La Roche-sur-yon
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
RECRUITING
Limoges
Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
RECRUITING
Nantes
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
RECRUITING
Strasbourg
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
RECRUITING
Tours
Germany
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
RECRUITING
Cologne
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
RECRUITING
Dresden
Universitaetsklinikum Essen | Klinik für Anaesthesiologie und Intensivmedizin
NOT_YET_RECRUITING
Essen
Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Klinik für Anaesthesiologie und Operative Intensivmedizin
WITHDRAWN
Kiel
RKH Klinikum Ludwigsburg
NOT_YET_RECRUITING
Ludwigsburg
Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
NOT_YET_RECRUITING
München
Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Anestesia e TI Polivalente
RECRUITING
Bologna
Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Carlo - Anestesia e Rianimazione
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica
RECRUITING
Roma
Humanitas Mirasole S.p.A. - Anestesia e Terapie Intensive
RECRUITING
Rozzano
Netherlands
Medisch Spectrum Twente - Intensive Care
RECRUITING
Enschede
Universitair Medisch Centrum St. Radboud
NOT_YET_RECRUITING
Nijmegen
Maasstad
RECRUITING
Rotterdam
Spain
Hospital Universitari Vall d´Hebron_ Nefrologia
RECRUITING
Barcelona
Hospital Universitario de Getafe - UCI
RECRUITING
Getafe
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Central de Asturias
RECRUITING
Oviedo
Hospital Virgen del Rocio
RECRUITING
Seville
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2025-01-29
Estimated Completion Date: 2026-04-07
Participants
Target number of participants: 150
Treatments
Other: Septic participants in ICU
The study population will consist of septic participants admitted to a medical intensive care unit (ICU), as defined in the inclusion criteria. No investigational study interventions will be administered in this study. Participants will undergo therapeutic and diagnostic procedures as per local standard medical care and as deemed appropriate by the treating physicians. Collection of blood and of available clinical data are the only activities performed in addition.
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov