Alirocumab in Patients with Sepsis (NCT05469347) | Clinical Trial Compass
CompletedPhase 1
Alirocumab in Patients with Sepsis
United States50 participantsStarted 2023-01-04
Plain-language summary
The purpose of this study is to determine whether the drug alirocumab, which may lower cholesterol, can reduce the amount of inflammation caused by an infection that has caused either low blood pressure or difficulty breathing. Participants will be randomized to receive a single IV infusion of alirocumab or a placebo.
Who can participate
Age range18 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Suspected or confirmed infection as evidenced by ordering of blood cultures and administration of at least one antimicrobial agent
* Acute respiratory or cardiovascular organ dysfunction attributed to sepsis as evidenced by at least one of the following requirements:
* Vasopressor Requirement - Continuous infusion of norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine or other vasopressor agents at any dose for greater than 1 hour and required to maintain a mean arterial pressure ≥ 65 mm Hg despite intravenous crystalloid infusion of at least 1000cc
* Respiratory Support Requirement - Acute hypoxemic respiratory failure defined as persistent hypoxemia requiring (1) intubation and mechanical ventilation, or (2) positive pressure ventilation via tight-fitting face mask or (3) high flow nasal cannula ≥ 45 liters per minute (LPM) flow and fraction of inspired oxygen (FiO2) ≥ 0.40
* Anticipated or confirmed intensive care unit (ICU) admission
Exclusion Criteria:
* Organ dysfunction present \> 24 hours at time randomization
* Limitations of care (defined as refusal of cardiovascular and respiratory support described under inclusion criteria) including "do not intubate" (DNI) status
* Development of sepsis while in the hospital ( i.e not present on admission to hospital)
* Chronic hypoxemia requiring supplemental non-invasive oxygen or home mechanical ventilation
* Chronic cardiovascular failure requiring home mechanical hemodynamic suppor…