A41.9 J10 U07.1
Conditions
Interventions
Group 1: Patients with COVID-19-associated sepsis (with indication for critical care)
• T1 (3 d ± 24 h after sepsis diagnosis):
o routine and study-specific blood tests
o echocardiography
o optional
Sponsors
Translational SeptomicsKlinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Jena
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - written informed consent of the patient or his legal representative - confirmed SARS-CoV-2 infection OR confirmed influenza virus infection. - respiratory symptoms - indication for ICU-therapy - sepsis or septic shock according to Sepsis-3 criteria - first infection-associated organ dysfunction (= sepsis diagnosis) no older than 4 days (first blood sample within 4 days after sepsis diagnosis)
Exclusion criteria
Exclusion criteria: • cardiac surgery = 12 months • significant pre-existing heart condition o endocarditis o higher-grade valvular heart disease o (grade 3 valve disease, symptomatic aortic stenosis, medium-degree mitral valve insufficiency with reduced ejection fraction or clinical symptoms) o complex structural congenital heart condition (TGA, Tetralogy of Fallot, endocardial cushion defect etc.) o hemodynamic relevant shunt deficit o pre-existing significantly reduced cardiac performance o (ejection fraction < 45 % or 10 % below norm value) o pre-existing pulmonary hypertension o myocardial infarction = 1 year in patient history o heart transplantation in patient history • cardiopulmonary resuscitation<4 weeks before sepsis begin • pneumonectomy in medical history • liver cirrhosis Child C • contraindication for transesophageal echocardiography (e.g. esophageal resection, higher-grade esophagus varices) and insufficient sonography conditions for transthoracic echocardiography • terminal kidney disease with dialysis • Sepsis/septic shock = 8 months • pregnancy/breastfeeding • therapy limitation, DNR / DNI order • life expectancy = 6 months due to comorbidities • previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in mortality rates between COVID-19-sepsis patients with vs. without septic cardiomyopathy 3 months after diagnosis of COVID-19-sepsis (T5) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Differences in mortality rates between COVID-19-sepsis patients with vs. without septic cardiomyopathy 6 months after diagnosis of COVID-19-sepsis (T6) - Incidence of cardiovascular events in patients with COVID 19-sepsis during the acute (T1, T2), post-acute (T3-T4) and long-term course of disease (T5-T6) - Differences in the incidence rates of septic cardiomyopathy during the acute course of disease (T1, T2) in patients with COVID-19-sepsis and patients with influenza-sepsis - Differences in the incidence rates of cardiovascular events in patients with COVID 19-sepsis and patients with influenza-sepsis during the acute (T1, T2), post-acute (T3-T4) and long-term course of disease (T5-T6) For further research questions patients with COVID-19-sepsis and patients with influenza-associated sepsis as well as pre-existing cohorts of patients with non-COVID-19-associated sepsis and healthy volunteers will be compared. For this purpose, further outcome measures including cardiovascular risk factors and function, liver/kidney stiffness, organ dysfunction, immune status, metabolome, lipidome and general functional level, will be analysed: - differences in the occurence of septic cadiomyopathy between patients with COVID-19-sepsis and non-COVID-19-associated sepsis during the acute disease (cumulative T1 and T2) - identification of COVID 19-specific clinical and molecular changes in the acute and post-acute course of disease - analysis of potential group differences in the acute and post-acute course of disease (complete sample and stratified by the occurence of septic cardiomyopathy) to identify varaibles with potential diagnostic relevance in COVID-19-sepsis - characterisation of the acute and post-acute course of diseas in patients with COVID-19-sepsis (complete sample and stratified by the occurence of septic cardiomyopathy) to explore potential surrogate paramters for the occurence of cardial dysfunction - comparison of the incidence of right heart f | — |
Countries
Germany
Contacts
Public ContactMarkus Engelmann
Translational SeptomicsKlinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Jena
Outcome results
None listed