Last updated on January 2019

Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Toxic Shock Syndrome
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Written informed consent by patient or legal representative (according to country - specific regulations)
  2. Male and female patient, age 18 years
  3. Body weight 50 kg - 120 kg
  4. Bio-ADM concentration > 70 pg/ml
  5. Patient with early septic shock (start of vasopressor therapy < 12 hours)

Exclusion Criteria:

  1. Moribund and death is considered imminent< 28 days
  2. Pre-existing unstable condition (e.g. a recent cerebral hemorrhage or infarct, a recent acute unstable myocardial infarction (all < 3 months), congestive heart failure
    • New York Heart Association (NYHA) Class IV
  3. Patients that required cardiopulmonary resuscitation in the last 4 weeks prior to evaluation for enrollment
  4. Severe Chronic Obstructive Pulmonary Disease (COPD) with chronic oxygen need at home (GOLD IV)
  5. Any organ or bone marrow transplant within the past 24 weeks
  6. Uncontrolled serious hemorrhage ( 2 units of blood / platelets in the previous 24 hrs.). Patients may be considered for enrollment if bleeding has stopped and patient is otherwise qualified
  7. Uncontrolled hematological / oncological malignancies
  8. Immunosuppressed patients (known HIV, absolute neutropenia < 500 per L)
  9. Treatment with immunosuppressive drugs
  10. Severe chronic liver disease (Child-Pugh C)
  11. Systemic fungal infection or active tuberculosis
  12. Neuromuscular disorders that impact breathing / spontaneous ventilation
  13. Burns > 30% of body surface
  14. Plasmapheresis
  15. Women who are pregnant or nursing
  16. Participation in a clinical trial involving another investigational drug within 4 weeks prior to inclusion
  17. Unwilling or unable to be fully evaluated for all follow-up visits -

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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