Sepsis, Sepsis Associated DIC
Conditions
Keywords
Sepsis, DIC
Brief 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.
Interventions
OTHERLocal standard medical care
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
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients deferred from other Intensive Care Units (ICUs). * Patients longer than 24 hours on ICU. * Known coagulation disorder. * Ongoing active clinically significant bleeding. * Participants experienced trauma or major surgery (within 4 weeks). * Active malignancy. * Decompensated liver impairment Child-Pugh Class C. * Moribund patients not expected to survive 24 hours (clinical decision). * Ongoing therapeutic anticoagulation (prophylactic dose of Unfractionated Heparin \[UFH\]/Low Molecular Weight Heparin \[LMWH\] is allowed) or antiplatelet therapy (except low dose \[≤100 mg\] acetyl salicylic acid \[ASA\]). If previously named treatment can be stopped the participants will be eligible if a "wash out"-time of five half-lives is applied before start of study. * Patients who have received any investigational drug involving pharmacological interventions, or biological or cell therapy interventions or prohibited therapy within 28 days or five half-lives, whichever is longer, prior to screening/baseline. * Any reason that would make participation unadvisable, at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Disseminated Intravascular Coagulation (DIC) as defined by ISTH criteria | Until Day 56 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA) score at baseline | 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. |
| Change from baseline in SOFA score on Day 5 or End of ICU stay, whichever happens first | Baseline and Day 5 or End of ICU stay | 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. |
| All-cause mortality until Day 56 | Until Day 56 | — |
| Type of organ support status until Day 56 | Until Day 56 | Describe the type of organ support status. |
| Time with organ support status until Day 56 | Until Day 56 | Describe the time with organ support status. |
| Type of hospitalization status until Day 56 | Until Day 56 | Describe the type of hospitalization (ICU \[Intensive Care Unit\]/ common ward/ discharge). |
| Time with hospitalization until Day 56 | Until Day 56 | Describe the time with hospitalization. |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed