None listed
Conditions
Brief summary
Sepsis is a life-threatening illness secondary to a hosts dysregulated inflammatory response to an infection leading to organ failure. The mainstay of sepsis management involves eradication of the pathogen with antibiotics and mitigation of end organ damage, which can occur even after the infection has cleared due to the continued inflammatory response. PCSK9 inhibitors have shown potential in the treatment of sepsis by increasing removal of lipids found in the microbial cell walls that activate the immune system, trigger cytokine release and dysregulated systemic inflammation, hence their potential as a treatment target. Our hypothesis is that PCSK9 inhibitor treatment will accelerate the removal of the microbial wall lipids and will stop the dysregulation of the immune system bringing faster resolution of the sepsis. We intend to treat sepsis patients in the ICU with PCSK9 inhibitors upon admission.
Interventions
Post randomization upon admission to the ICU patients diagnosed with sepsis, will receive a subcutaneous injection of Alirocumab 150mg once, Time of administration will be recorded and monitored if in the intervention group.
The intervention group will receive the standard treatment for sepsis / septic shock without any change.
Sponsors
Dr. Ziv Rosman - Dunedin hospital ICU
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Admission to the ICU with diagnosis of sepsis or septic shock Randomized within 24 hours from diagnosis of sepsis or septic shock
Exclusion criteria
More than 24 hours from diagnosis of sepsis or septic shock under 18 Pregnant Anticipated death within 24 hours Liver failure (measured as Child Pugh B or C) Use of Alirocumab within the last 6 months Known hypersensitivity to PCSK9 inhibitor
Outcome results
None listed