Clinical trial NCT02141607: Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
Official title: Multiscale Approach to Describe the Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Shock
Keywords: shock
heart failure
inflammation
biomarkers
cardiovascular instability
metabolic pathways
proteolysis
Lead sponsor: Shockomics Consortium
Sponsor class: NETWORK
Collaborators: name: Seventh Framework Programme
First posted: 2014-05-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients admitted to ICU

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression/occurrence of acute heart failure and changes in omics markers in acute phase of shock
timeFrame: within 48 hr after admission in ICU (acute phase of shock)
Secondary outcomes:
measure: Progression/Occurence of Acute Heart Failure and changes in omics markers in survivors
timeFrame: within 7 days after admission in ICU (patient stabilization)
Other outcomes:
measure: Long term effects of AHF in survivors assessed by changes in omics markers
timeFrame: at about 100 days from ICU admission and enrollment
Locations:
city: Brussels
country: Belgium
facility: Department of Intensive Care, Erasme University Hospital
city: Barcelona
country: Spain
facility: Servei de Medicina Intensiva, Hospital Universitari Mútua Terrassa
city: Geneva
country: Switzerland
facility: Intensive Care Division, Geneva University Hospitals
Study officials:
affiliation: Politecnico di Milano
name: Giuseppe Baselli, MS
role: PRINCIPAL_INVESTIGATOR
References:
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/SHK.0000000000001046.
citation: 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: 10.1038/s41598-017-09619-x.
citation: Braga D, Barcella M, Herpain A, Aletti F, Kistler EB, Bollen Pinto B, Bendjelid K, Barlassina C. A longitudinal study highlights shared aspects of the transcriptomic response to cardiogenic and septic shock. Crit Care. 2019 Dec 19;23(1):414. doi: 10.1186/s13054-019-2670-8.
citation: Bauza-Martinez J, Aletti F, Pinto BB, Ribas V, Odena MA, Diaz R, Romay E, Ferrer R, Kistler EB, Tedeschi G, Schmid-Schonbein GW, Herpain A, Bendjelid K, de Oliveira E. Proteolysis in septic shock patients: plasma peptidomic patterns are associated with mortality. Br J Anaesth. 2018 Nov;121(5):1065-1074. doi: 10.1016/j.bja.2018.05.072. Epub 2018 Jul 26.
citation: Aletti F, Conti C, Ferrario M, Ribas V, Bollen Pinto B, Herpain A, Post E, Romay Medina E, Barlassina C, de Oliveira E, Pastorelli R, Tedeschi G, Ristagno G, Taccone FS, Schmid-Schonbein GW, Ferrer R, De Backer D, Bendjelid K, Baselli G. ShockOmics: multiscale approach to the identification of molecular biomarkers in acute heart failure induced by shock. Scand J Trauma Resusc Emerg Med. 2016 Jan 28;24:9. doi: 10.1186/s13049-016-0197-4.
citation: Carrara M, Baselli G, Ferrario M. Mortality prediction in septic shock patients: Towards new personalized models in critical care. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:2792-5. doi: 10.1109/EMBC.2015.7318971.