Cardiovascular illness, Intensive care unit (ICU), open-heart surgery
Conditions
Brief summary
The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery
Detailed description
30 day and 6-month all-cause mortality, Days alive and out of hospital, Time to discharge alive (TDA), Persistent organ dysfunction and death, ICU and hospital length of stay, ICU and hospital readmission rates, Area under the curve (AUC) of inflammatory markers (IL-1b, TNF-α and IFN-γ), Absolute values of daily measurements of C Reactive Protein (CRP), procalcitonin (PCT) and leukocytes during ICU stay, Daily overall Sequential Organ Failure Assessment (SOFA) Score, Duration and type (invasive or non-invasive) of mechanical ventilation, Duration and dosage of sedative agents used postoperatively, Occurrence of malignant arrhythmias, Occurrence of atrial fibrillation, Left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) Classification, Number of cerebral ischemic or hemorrhagic events, Clinical Frailty Scale (CFS), Daily Confusion Assessment Method for the ICU (CAM-ICU) Score, Urine output during the ICU length of stay, Number of post operative complications including surgical re-evaluation, severe hemorrhage requiring surgical intervention, thromboembolic events requiring intervention, infection and sepsis, Adverse Events leading to discontinuation/Adverse Events at least possibly related to the IMP/Serious Adverse Events and Adverse Events of Special Interest, Entzündungsmarker, die mit Point-of-Care-Methoden am Krankenbett analysiert werden (z. B. IL-1, IL-6, IL-8, IL-10, TNF-α, IFN-γ, CRP, PCT, D-Dimer, Ferritin)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 30 day and 6-month all-cause mortality, Days alive and out of hospital, Time to discharge alive (TDA), Persistent organ dysfunction and death, ICU and hospital length of stay, ICU and hospital readmission rates, Area under the curve (AUC) of inflammatory markers (IL-1b, TNF-α and IFN-γ), Absolute values of daily measurements of C Reactive Protein (CRP), procalcitonin (PCT) and leukocytes during ICU stay, Daily overall Sequential Organ Failure Assessment (SOFA) Score, Duration and type (invasive or non-invasive) of mechanical ventilation, Duration and dosage of sedative agents used postoperatively, Occurrence of malignant arrhythmias, Occurrence of atrial fibrillation, Left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) Classification, Number of cerebral ischemic or hemorrhagic events, Clinical Frailty Scale (CFS), Daily Confusion Assessment Method for the ICU (CAM-ICU) Score, Urine output during the ICU length of stay, Number of post operative complications inc | — |
Countries
Germany