Acute Heart FailureShockomicsNCT02141607
Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
An observational study of Acute Heart Failure and Shock, run by Shockomics Consortium at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Heart Failure, Shock
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2014to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All the patients admitted to ICU
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Belgium1 site
Department of Intensive Care, Erasme University Hospital
Brussels
Spain1 site
Servei de Medicina Intensiva, Hospital Universitari Mútua Terrassa
Barcelona
Switzerland1 site
Intensive Care Division, Geneva University Hospitals
Geneva
About this study
Official title: Multiscale Approach to Describe the Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
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.
- Conditions
- Acute Heart Failure, Shock
- Keywords
- shock, heart failure, inflammation, biomarkers, cardiovascular instability, metabolic pathways, proteolysis
- Medical subject headings
- Shock, Heart Failure, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhagic Shock | Hypovolemic shock characterized by: * Hypotension: systolic blood pressure < 90 mm Hg or a drop of > 40 mm Hg from baseline or mean arterial pressure < 70 mm Hg persisting despite adequate fluid resuscitation. * Rapid loss of significant amount of blood * Lactate levels ≥ 2 mmol/L | |
| Cardiogenic shock | State of inadequate circulation of blood because of ventricular failure due to acute cardiac conditions, concomitant presence of: * Hypotension: systolic blood pressure < 90 mm Hg or a drop of > 40 mm Hg from baseline or mean arterial pressure < 70 mm Hg persisting despite adequate fluid resuscitation. * Need for a continuous infusion of inotropic drugs * Cardiac Index <2.2 L/min/m2 or use of inotropic drugs (dobutamine/isoprenaline/phosphodiesterase inhibitors or levosimendan) * Signs of reduced heart function * Cardiac overload or altered left/right ventricular function | |
| Septic shock | Septic shock is defined as sepsis-induced hypotension, defined as systolic blood pressure < 90 mm Hg or a drop of > 40 mm Hg from baseline or mean arterial pressure < 70 mm Hg persisting despite adequate fluid resuscitation. Only community medical acquired sepsis with a sepsis onset within 48 hours from hospital admission (i.e. different from nosocomial infection). Lactate levels ≥ 2mmol/L. | |
| control group | The control group will consist on: 1. 5 healthy blood donors: serving only for the purposes of obtaining reference values for proteomics analysis 2. a cohort of 20 patients hospitalized for sepsis OR cardiac syndromes not developing shock: will be recruited from patients admitted to the hospital during the study period. The clinical status of the patients will be assessed during hospitalization to ascertain shock and AHF development. Shock development will be an exclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 48 hr after admission in ICU (acute phase of shock)
Secondary outcomes (1)
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
Measured: within 7 days after admission in ICU (patient stabilization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockomics Consortium
- Sponsor type
- Research network
- Collaborators
- Seventh Framework Programme
- Responsible party
- Sponsor
- Investigators
- Giuseppe Baselli, MS, Principal investigator, Politecnico di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141607
- Sponsor's protocol ID
- FP7#602706
- Other IDs
- 602706
- Acronym
- Shockomics
- Status last verified
- Jun 2018
- First submitted
- 8 May 2014
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29112634Cambiaghi 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.
PubMed 28851978Maegele M, Aletti F, Efron PA, Relja B, Orfanos SE. NEW INSIGHTS INTO THE PATHOPHYSIOLOGY OF TRAUMA AND HEMORRHAGE. Shock. 2023 Mar 1;59(3S Suppl 1):6-9. doi: 10.1097/SHK.0000000000001954. Epub 2022 Jul 24.
PubMed 36867756Braga 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.
PubMed 31856860Bauza-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.
PubMed 30336851Aletti 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.
PubMed 26822963Carrara 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.
PubMed 26736871
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiscale Approach to Describe the Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
- ClinicalTrials.gov ID
- NCT02141607
- Acronym / sponsor ID
- Shockomics / FP7#602706
- Conditions
- Acute Heart Failure, Shock
- Keywords
- shock, heart failure, inflammation, biomarkers, cardiovascular instability, metabolic pathways, proteolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shockomics ConsortiumResearch network
- Collaborators
- Seventh Framework Programme
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hemorrhagic Shock | – | –Hypovolemic shock characterized by: * Hypotension: systolic blood pressure < 90 mm Hg or a drop of > 40 mm Hg from baseline or mean arterial pressure < 70 mm Hg persisting despite adequate fluid resuscitation. * Rapid loss of significant amount of blood * Lactate levels ≥ 2 mmol/L |
| Cardiogenic shock | – | –State of inadequate circulation of blood because of ventricular failure due to acute cardiac conditions, concomitant presence of: * Hypotension: systolic blood pressure < 90 mm Hg or a drop of > 40 mm Hg from baseline or mean arterial pressure < 70 mm Hg persisting despite adequate fluid resuscitation. * Need for a continuous infusion of inotropic drugs * Cardiac Index <2.2 L/min/m2 or use of inotropic drugs (dobutamine/isoprenaline/phosphodiesterase inhibitors or levosimendan) * Signs of reduced heart function * Cardiac overload or altered left/right ventricular function |
| Septic shock | – | –Septic shock is defined as sepsis-induced hypotension, defined as systolic blood pressure < 90 mm Hg or a drop of > 40 mm Hg from baseline or mean arterial pressure < 70 mm Hg persisting despite adequate fluid resuscitation. Only community medical acquired sepsis with a sepsis onset within 48 hours from hospital admission (i.e. different from nosocomial infection). Lactate levels ≥ 2mmol/L. |
| control group | – | –The control group will consist on: 1. 5 healthy blood donors: serving only for the purposes of obtaining reference values for proteomics analysis 2. a cohort of 20 patients hospitalized for sepsis OR cardiac syndromes not developing shock: will be recruited from patients admitted to the hospital during the study period. The clinical status of the patients will be assessed during hospitalization to ascertain shock and AHF development. Shock development will be an exclusion criteria. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients admitted to ICU
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression/occurrence of acute heart failure and changes in omics markers in acute phase of shock
Time frame: 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.
1 secondary outcome
Progression/Occurence of Acute Heart Failure and changes in omics markers in survivors
Time frame: within 7 days after admission in ICU (patient stabilization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Results publication: PubMed 29112634Carrara 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.
- Results publication: PubMed 28851978Cambiaghi 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.
- Derived from this study: PubMed 36867756Maegele M, Aletti F, Efron PA, Relja B, Orfanos SE. NEW INSIGHTS INTO THE PATHOPHYSIOLOGY OF TRAUMA AND HEMORRHAGE. Shock. 2023 Mar 1;59(3S Suppl 1):6-9. doi: 10.1097/SHK.0000000000001954. Epub 2022 Jul 24.
- Derived from this study: PubMed 31856860Braga 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.
- Derived from this study: PubMed 30336851Bauza-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.
- Derived from this study: PubMed 26822963Aletti 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.
- Derived from this study: PubMed 26736871Carrara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Baselli, MS principal investigator
Politecnico di Milano
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure and Shock, run by Shockomics Consortium at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression/occurrence of acute heart failure and changes in omics markers in acute phase of shock (time frame: within 48 hr after admission in ICU (acute phase of shock)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02141607, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.