Status:
UNKNOWN
Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study)
Lead Sponsor:
University of British Columbia
Conditions:
Sepsis
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This study evaluates using evolocumab, a currently approved and marketed biologic drug, in a novel way. Patients who present to the emergency room or intensive care unit (ICU) with severe infection ar...
Detailed Description
Evolocumab is currently approved and marketed in USA and Canada for lowering cholesterol levels. Evolocumab is an anti-PSCK9 monoclonal antibody, and functions by binding PSCK9 (an inhibitor of LDL re...
Eligibility Criteria
Inclusion
- Signed informed consent
- At least 19 years of age
- Known or suspected infection
- AND one or more of the following organ dysfunctions judged due to sepsis:
- Cardiovascular- refractory hypotension (a systolic blood pressure (SBP) \< 90 mm Hg or mean arterial pressure (MAP) \< 60 mm Hg despite an IV fluid challenge of at least 30 ml/kg fluids), or use of vasopressor(s) to maintain SAP \> 90 mm Hg or MAP \> 60 mm Hg, or;
- Respiratory: PaO2/FiO2 \< 300 or PaO2/FiO2 \< 200 if lung is the only organ dysfunction or SaO2:FiO2 150
Exclusion
- Known pregnancy
- Underlying severe congestive heart failure (New York Heart Association (NYHA) IV), severe COPD (need for chronic oxygen or mechanical ventilation), severe liver disease (Child-Pugh Class C), cancer requiring chemotherapy, or transplantation (bone marrow, heart, lung, liver, pancreas, or small bowel) in the past 6 months or likely within the next 6 months
- Previous episode of sepsis during that hospital admission
- Absolute Neutrophil Count \< 500/mm³
- CD4 count \< 50/mm³
- Treating physician deems aggressive care unsuitable (i.e. no commitment to active care)
- Participation in another interventional drug study within previous 1 month
- Allergic to the study drug or any of its components
- Lactation
- Have signed a Do No Resuscitate (DNR) Form
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 11 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03869073
Start Date
February 11 2019
End Date
February 11 2021
Last Update
March 3 2020
Active Locations (3)
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1
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V 1Z2
2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
3
Vancouver General Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6