Treatment of Severe Infection With Antihyperlipidemia Drug

• Status: Unknown status
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wolfson Medical Center
• Collaborators: Assaf-Harofeh Medical Center; Sanofi
• Treatments: Antibodies, Monoclonal

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.