The primary purpose of this study is to enhance the understanding of the disease progression in sepsis, particularly from ICU admission to the development of DIC. This will be achieved by investigating the association between various biomarkers with…
ID
Source
Brief title
Condition
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective: Quantification and assessment of the association of
(combinations of) biomarkers and standard clinical and demographic
characteristics with the (non-) occurrence of DIC. Both baseline levels as well
as the longitudinal development of such markers will be of interest.
Primary endpoint: Occurrence of DIC as defined by ISTH criteria.
Secondary outcome
Secondary objective: Quantification and assessment of the association of
(combinations of) biomarkers and standard clinical and demographic
characteristics with a range of ICU related clinical endpoints. Both baseline
levels as well as the longitudinal development of such markers will be of
interest.
Secondary endpoints:
• SOFA score at baseline
• SOFA score (change from baseline on Day 5 or End of ICU stay, whichever
happens first)
• All-cause mortality until Day 56
• Organ support status until Day 56
• Hospitalization status until Day 56
Background summary
Septic DIC is a complex condition characterized by systemic activation of blood
coagulation, leading to microvascular thrombosis and consumption of clotting
factors and platelets. This condition is caused by a strong inflammatory
response to infections, usually bacterial, which releases pro-inflammatory
cytokines that activate the coagulation cascade. This results in an imbalance
between pro-coagulant and anti-coagulant factors, leading to the formation of
microthrombi and an increased risk of bleeding. The current treatment focuses
on addressing the underlying infection and supporting organ function, but there
are significant medical needs due to the complexity and severity of the
condition.
Study objective
The primary purpose of this study is to enhance the understanding of the
disease progression in sepsis, particularly from ICU admission to the
development of DIC. This will be achieved by investigating the association
between various biomarkers with respect to underlying molecular pathways and
mechanisms and standard clinical and demographic parameters with the occurrence
and progression of DIC.
Study design
This is an exploratory study in patients with sepsis. No study drug application
is planned. The assumed study duration is 15 months.
Study burden and risks
The risks associated with this study are primarily related to the collection of
blood samples, but these do not significantly interfere with standard care.
Blood collection usually occurs simultaneously with regular clinical
examinations, which means there are no additional procedural risks.
Participants will not personally benefit from the study; the aim is to enhance
the understanding of the molecular pathophysiology of DIC in sepsis and to
identify biomarkers. The benefits of the study, such as improving the early
identification of at-risk patients and developing new therapeutic strategies,
outweigh the manageable risks.
Siriusdreef 36
Hoofddorp 2130 AB
NL
Siriusdreef 36
Hoofddorp 2130 AB
NL
Listed location countries
Age
Inclusion criteria
1. Participant must be 18 years of age inclusive, at the time of signing the
informed consent.
2. Participants with diagnosed sepsis according to sepsis-3 definition.
3. Participants with documented suspected origin of infection.
Exclusion criteria
1. Patients deferred from other ICUs
2. Patients longer than 24 hours on ICU
3. Known coagulation disorder
4. Ongoing active clinically significant bleeding
5. Participants experienced trauma or major surgery (within 4 weeks)
6. Active malignancy
7. Decompensated liver impairment Child-Pugh Class C
8. Moribund patients not expected to survive 24 hours (clinical decision)
9. Ongoing therapeutic anticoagulation (prophylactic dose of UFH/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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87949.091.24 |