Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock

Completed

• Conditions: Acute Heart Failure; Shock

• Registration Number: NCT02141607
• Lead Sponsor: Shockomics Consortium

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-19
• Study Start: 2014-10
• Primary Completion: 2016-06
• Study Completion: 2017-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Intensive Care Division, Geneva University Hospitals; 🇨🇭 Geneva, Switzerland

Department of Intensive Care, Erasme University Hospital; 🇧🇪 Brussels, Belgium

Servei de Medicina Intensiva, Hospital Universitari Mútua Terrassa; 🇪🇸 Barcelona, Spain