Acute Heart Failure, Shock
Conditions
Keywords
shock, heart failure, inflammation, biomarkers, cardiovascular instability, metabolic pathways, proteolysis
Brief summary
The relationship between shock, ischemia and reperfusion (I/R) injury, hemodynamic instability, systemic inflammatory response syndrome and multiorgan failure has been extensively investigated, but there is no consensus on the trigger mechanisms of tissue injury at the molecular level. Current therapies are targeted to reduce symptoms of shock and multiorgan damage but they are unable to act at the beginning of the cascade, because of the lack of a model explaining the molecular basis of shock induced tissue injury and ensuing organ damage. The present observational study is aimed at identifying the molecular triggers of acute heart failure (HF) induced by shock and to identify inflammatory mediators and markers that are activated in shock, with a particular emphasis on the role of uncontrolled proteolytic activity.
Interventions
None listed
Sponsors
Seventh Framework Programme
Shockomics Consortium
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* For patients in septic shock, Severity: SOFA score \> 5 * For patients in cardiogenic shock, Severity: SOFA score \> 5 * First blood sample available within 16 hours from admission to the ICU. * Only community medical acquired septic shock. We include patients with shock symptoms and shock diagnosis occurring within the first 48 hours from hospital admission * Informed Consent available
Exclusion criteria
* Risk of rapidly fatal illness and death within 24 hours * Patients already enrolled in other interventional studies * N \> 4 units of red blood cells transfused * Patients treated with plasma or whole blood * Active hematological malignancy * Metastatic cancer * Immunodepression, including transplant patients: HIV+, constitutive immune system deficiency, immunosuppressive therapy, systemic corticosteroids (aerosols allowed) * Patients with pre-existing end stage renal disease needing renal replacement therapy (RRT). The introduction of continuous veno-venous hemofiltration (CVVH), from the day of admission onward is allowed. * Cardiac surgery patients * Cirrhosis Child C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression/occurrence of acute heart failure and changes in omics markers in acute phase of shock | within 48 hr after admission in ICU (acute phase of shock) | The clinical endpoint will be Acute Heart Failure (AHF), assessed by a pool of measures/estimates of cardiac function and filling pressures, based on cardiac output monitoring, inotropic drugs requirements, left and right ventricles assessment using echocardiography. The molecular biomarkers changes will be evaluated by means of proteomics, transcriptomics and metabolomics analysis of blood samples collected at the ICU admission and within 48hr after admission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression/Occurence of Acute Heart Failure and changes in omics markers in survivors | within 7 days after admission in ICU (patient stabilization) | The clinical endpoints will be: 1. The Acute Heart Failure (AHF) assessed by a pool of measures/estimates of cardiac function and filling pressures, based on cardiac output monitoring, inotropic drugs requirements, left and right ventricles assessment using echocardiography. AHF will be at evaluated within 7 days after ICU admission. 2. Mechanical ventilation (MV)-free days or organ support (vasopressor, continuous renal replacement therapy (CRRT), etc.) free-days 3. Survival to ICU 4. Prognosis at discharge from the ICU (objective - dead or alive, morbidities - and subjective) 5. Prognosis at discharge from the hospital (objective - dead or alive, morbidities - and subjective). The changes in molecular biomarkers will be evaluated by means of proteomics, transcriptomics and metabolomics analysis of blood samples collected within 7 days after ICU admission |
Other
| Measure | Time frame | Description |
|---|---|---|
| Long term effects of AHF in survivors assessed by changes in omics markers | at about 100 days from ICU admission and enrollment | Patients discharged after a shock episode have high morbidity and mortality rates, and evidences indicate that physiological condition is restored only after several months. The blood sample will be collected only in patients in healthy conditions, reporting no re-hospitalization associated to shock sequelae during the follow up. |
Countries
Belgium, Spain, Switzerland
Outcome results
None listed