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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
150
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.
MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin
Innsbruck, Tyrol, Austria
MedUni Graz | Innere Medizin, ICU
Graz, Austria
MedUni Wien | Univ. Klinik für Klinische Pharmakologie
Vienna, Austria
AZ Groeninge - Campus Kennedylaan
Kortrijk, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, Belgium
Occurrence of Disseminated Intravascular Coagulation (DIC) as defined by ISTH criteria
The International Society on Thrombosis and Haemostasis (ISTH) developed a scoring system to aid in the diagnosis and management of DIC. The ISTH DIC score is a standardized tool that quantifies the severity of DIC based on specific laboratory parameters. The total score ranges from 0 to 8, with a score of ≥ 4 indicating overt DIC. In this study, the ISTH DIC score will be employed for screening purposes as well as to evaluate the presence and severity of DIC in participants enrolled.
Time frame: Until Day 56
Sequential Organ Failure Assessment (SOFA) score at baseline
The Sequential Organ Failure Assessment (SOFA) score is a clinical tool used to track a patient's status in regard to the organ systems during stay in an Intensive Care Unit (ICU), assigning a score from 0 (normal function) to 4 (high degree of dysfunction) for each system. The total SOFA can range from 0 to 24.
Time frame: At baseline
Change from baseline in SOFA score on Day 5 or End of ICU stay, whichever happens first
The Sequential Organ Failure Assessment (SOFA) score is a clinical tool used to track a patient's status in regard to the organ systems during stay in an Intensive Care Unit (ICU), assigning a score from 0 (normal function) to 4 (high degree of dysfunction) for each system. The total SOFA can range from 0 to 24.
Time frame: Baseline and Day 5 or End of ICU stay
All-cause mortality until Day 56
Time frame: Until Day 56
Type of organ support status until Day 56
Describe the type of organ support status.
Time frame: Until Day 56
Time with organ support status until Day 56
Describe the time with organ support status.
Time frame: Until Day 56
Type of hospitalization status until Day 56
Describe the type of hospitalization (ICU \[Intensive Care Unit\]/ common ward/ discharge).
Time frame: Until Day 56
Time with hospitalization until Day 56
Describe the time with hospitalization.
Time frame: Until Day 56
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinique Saint-Pierre d'Ottignies - Intensive Care
Ottignies-Louvain-la-Neuve, Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
Angers, France
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
Garches, France
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-sur-Yon, France
...and 21 more locations