Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock

Shock Clinical Trial

— Shockomics  

Official title:

Multiscale Approach to Describe the Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141607
• Other study ID #: FP7#602706
• Secondary ID: 602706
• Status: Completed
• Start date: October 2014
• Est. completion date: September 2017

Study information

• Verified date: June 2018
• Source: Shockomics Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure
• Shock

Locations

Country	Name	City	State
Belgium	Department of Intensive Care, Erasme University Hospital	Brussels
Spain	Servei de Medicina Intensiva, Hospital Universitari Mútua Terrassa	Barcelona
Switzerland	Intensive Care Division, Geneva University Hospitals	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Shockomics Consortium	Seventh Framework Programme

Countries where clinical trial is conducted

Belgium,  Spain,  Switzerland, 

References & Publications (2)

Cambiaghi A, Pinto BB, Brunelli L, Falcetta F, Aletti F, Bendjelid K, Pastorelli R, Ferrario M. Characterization of a metabolomic profile associated with responsiveness to therapy in the acute phase of septic shock. Sci Rep. 2017 Aug 29;7(1):9748. doi: 10 — View Citation

Carrara M, Bollen Pinto B, Baselli G, Bendjelid K, Ferrario M. Baroreflex Sensitivity and Blood Pressure Variability can Help in Understanding the Different Response to Therapy During Acute Phase of Septic Shock. Shock. 2018 Jul;50(1):78-86. doi: 10.1097/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long term effects of AHF in survivors assessed by changes in omics markers	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.	at about 100 days from ICU admission and enrollment
Primary	Progression/occurrence of acute heart failure and changes in omics markers in 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.	within 48 hr after admission in ICU (acute phase of shock)
Secondary	Progression/Occurence of Acute Heart Failure and changes in omics markers in survivors	The clinical endpoints will be: 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.; Mechanical ventilation (MV)-free days or organ support (vasopressor, continuous renal replacement therapy (CRRT), etc.) free-days; Survival to ICU; Prognosis at discharge from the ICU (objective - dead or alive, morbidities - and subjective); 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	within 7 days after admission in ICU (patient stabilization)

External Links

•   EU project website