In this study we aim to develop a predictive model for septic ICU*patients enabling the clinician to make a customized risk stratification and asses the patient*s immune status.
ID
Source
Brief title
Condition
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mortality is the primary study endpoint.
Secondary outcome
Secondary endpoints include pathogen etiology, systemic inflammatory parameters
and MODS. The secondary endpoints will enable us to develop a predictive model
for risk stratification for sepsis and provides insight in the pathophysiologic
processes of sepsis and might lead to novel therapeutic interventions.
Background summary
Sepsis is a common clinical entity in Intensive Care Unit (ICU)*patients.
Despite many years of research, sepsis is still the second leading cause of
death in these patients. Sepsis occurs as a complication of a local infection
when microorganisms invade the host*s bloodstream and cause systemic
inflammation. The systemic response to pathogens can lead to a disproportionate
activation of pro* and anti*inflammatory mediators, resulting in a state of
hyperinflammation. This exaggerated immune response can induce organ
dysfunction and results in the multi organ dysfunction syndrome (MODS).
Through the years, investigating the pathophysiology of sepsis has proven to be
extremely difficult due to the heterogeneous character of this disease with its
multiplicity in etiology and the complex immune system as effector.
Study objective
In this study we aim to develop a predictive model for septic ICU*patients
enabling the clinician to make a customized risk stratification and asses the
patient*s immune status.
Study design
This is a longitudinal observational study.
Study burden and risks
All patients are subjected to collection of blood samples 3 times a day for 7
consecutive days.
Patients will not directly benefit from participating in this study due to it*s
observational design. Future patients with sepsis, however, could benefit of
the outcome of this study. During this study participating patients will not be
exposed to any additional health risks.
During this study, patients will be subjected to a daily blood draw of 13.5 ml
per day. Considering this is a mere 0.2 percent of the total circulating
volume, this will not attribute to any of the patients burdens, nor result in
an additional risk.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Presence of an arterial line
- Patients who score positive for sepsis according to the Bone criteria (at least 2 SIRS criteria plus clinical suspicion of infection).
Exclusion criteria
- No informed consent.
- Patients receiving > 24 hours of antibiotic treatment for a suspected infection prior to ICU admission.
- Previous participation in this study.
Design
Recruitment
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 | NL35777.041.11 |