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NCT Number: NCT02141607

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.

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Key information

Conditions

Acute Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Intensive Care, Erasme University Hospital, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Progression/Occurence of Acute Heart Failure and changes in omics markers in survivors

    Time frame: within 7 days after admission in ICU (patient stabilization)

    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

Other outcomes

  1. Long term effects of AHF in survivors assessed by changes in omics markers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shockomics Consortium

Network

Collaborators

  • Seventh Framework Programme

Registry information

Official study title

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

Acronym: Shockomics

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 19, 2014
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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