NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Treatment of Severe Infection With Antihyperlipidemia Drug

UnknownPhase 2, Phase 3

Sponsor: Wolfson Medical Center

Conditions: Sepsis, Septic Shock

Interventions: Alirocumab Injectable Product, Saline Solution

Countries: Israel

Proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors increase LDL receptors by decreasing its degradation. In sepsis the pathogenic substances, endotoxin, lipoteichoic acid, phospholipomannan are the main cause of the ongoing inflammation that causes the severe damage and outcome. these substances are removed from the blood by the LDL receptors. By administering PCSK9 inhibitors to patients with sepsis/septic shock this inflammatory response can be stopped and by doing so improve the patients outcome.

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

* Inclusion Criteria:

  * Subject is admitted to the ICU
  * Subject has a clinical diagnosis of sepsis or septic shock
* Exclusion Criteria:

  * Liver function tests (aspartate aminotransferase and Alanine transaminase) above three times the normal levels.
  * Creatinine clearance levels below 30.
  * Life expectancy below 28 days due to terminal illness.
  * Moribund condition with life expectancy of less than 24 hours.
  * Pregnancy or lactating women.
  * Known hypersensitivity to the study drug.
  * Grade IV peripheral edema at time of randomization.

Locations (1)

Rishon LeZiyyon, Israel