Despite large efforts trying to improve diagnostic and therapy of sepsis have been made over the last decade (e.g. initiation of the Surviving Sepsis Campaign, defining evidence based sepsis therapy bundles) the mortality of septic shock remains high and causes high socioeconomical burden of disease. The purpose of this pilot study is to evaluate the design and conduct of a projected full scale clinical trial.
A functional clock is required for induction of several proinflammatory genes, not shown in septic patient settings, yet. Clock genes are involved in modulating the activity of several transcription factors that are important regulators of immune functions (e.g. HIF1-α, STAT1, STAT3, and NF-κB) (Bellet MM et al., 2013). Furthermore, polymorphisms such as rs7221412, a common polymorphism near period homolog 1 (PER1), was associated with the timing of activity rhythms and also showed a suggestive time-dependent relationship with both cerebral cortex and monocytes PER1 expression and an association with time of death (Lim ASP et al., 2012). This explorative project is a pilot study. First data are generated for the assessment of the circadian system in patients with septic shock.
Study Type
OBSERVATIONAL
Enrollment
20
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin
Berlin, Germany
Assessment of circadian regulation
Circadian regulation by expression of clock genes
Time frame: These parameters are measured during intensive care unit stay, for a maximum of 3 days
Time on mechanical ventilation
Time frame: They are followed up until the end of intensive care unit stay - or, for a maximum of 28 days
Intensive care unit length of stay
Time frame: Participants will be followed for the duration of intensive care stay, an expected average of 4 weeks
Hospital length of stay
Time frame: Participants will be followed for the duration of intensive care stay, an expected average of 5 weeks
Simplified Acute Physiology Score (SOFA II)
Time frame: They are measured until the end of intensive care unit stay - or, for a maximum of 28 days.
Sequential Organ Failure Assessment (SOFA)
Time frame: They are measured until the end of intensive care unit stay - or, for a maximum of 28 days.
Therapeutic Intervention Scoring System (TISS-28)
Time frame: They are measured until the end of intensive care unit stay - or, for a maximum of 28 days.
Mortality
Time frame: 6 months after intensive care unit discharge
Light frequencies
Time frame: Light frequencies are measured until the end of intensive care unit stay - or, for a maximum of 28 days
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Light levels (lux)
Time frame: Light levels are measured until the end of intensive care unit stay - or, for a maximum of 28 days
Cortisol
Time frame: This parameter is measured in ng/ml during intensive care unit stay, for a maximum of 3 days
Melatonin
Time frame: This parameter is measured in pg/ml during intensive care unit stay, for a maximum of 3 days
Quality of life
Quality of life is measured by SF-36 questionnaire
Time frame: Up to 3 and 6 months
Cognitive function
Cognitive function is measured by Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: Up to 3 and 6 months
Multiplex-Genexpression analysis
Ncounter neuroinflammation and micro rna panel are analysed
Time frame: These parameters are measured during intensive care unit stay, for a maximum of 3 days