Systemic inflammatory response
Conditions
Interventions
Group 1: Prospective observational study in adult patients (=18 years) admitted to the cardiac intensive care unit following cardiac surgery or for mechanical circulatory support (MCS).
Sponsors
Deutsches Herzzentrum der Charité (DHZC)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Admission to the cardiac intensive care unit following cardiac surgery or for treatment with mechanical circulatory support (MCS). 2) Written informed consent provided by the patient or a legally authorized representative in accordance with applicable legal requirements.
Exclusion criteria
Exclusion criteria: 1. Lack of valid informed consent. 2. Participation in another clinical study if this is expected to introduce relevant confounding factors or bias for the present study; assessed on a case-by-case basis by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) of serum concentrations of inflammatory biomarkers (e.g., IL-1, IL-2, IL-6, IL-8, IL-10, IL-15, TNF-a, IFN-?, MCP-1, CRP, PCT, D-dimer, ferritin, total MIF, oxidized MIF [oxMIF], MIF-2, and soluble CD74 [sCD74]) measured at four predefined time points (baseline, immediately after cardiac surgery or initiation of mechanical circulatory support [MCS], and 24 and 72 hours thereafter), representing the cumulative inflammatory burden during the first 72 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Longitudinal trajectories of individual inflammatory biomarkers across the predefined sampling time points. - Mortality (in-hospital mortality, 30-day, 6-month, and 12-month all-cause mortality). - Length of stay in the intensive care unit (ICU) and in hospital. - ICU readmission during the index hospitalization and hospital readmission within 30 days after discharge. - Duration of invasive and non-invasive mechanical ventilation. - Occurrence of postoperative complications, including atrial fibrillation and other cardiac arrhythmias, acute kidney injury (AKI), bleeding and thromboembolic complications, perioperative myocardial infarction, hemodynamic instability, pulmonary complications, acute respiratory distress syndrome (ARDS), neurological complications, infections, sepsis/septic shock, impaired wound healing, gastrointestinal complications, and delirium. Sequential Organ Failure Assessment (SOFA) score. - Quality of life and patient-reported outcomes assessed using validated instruments (e.g., EQ-5D-5L, SF-12, and Clinical Frailty Scale) at hospital discharge and at 3, 6, and 12 months of follow-up. | — |
Countries
Germany
Contacts
Public ContactMaren Kleine-Brüggeney
Deutsches Herzzentrum der Charité (DHZC)
Outcome results
None listed