NCT05725837

Effects of Paroxetine on Cardiovascular Function in Septic Patients

Effects of Paroxetine on Cardiovascular Function in Septic Patients: a Randomized Placebo Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is known that septic shock is characterized by arterial hypotension, decreased peripheral vascular resistance and hyporeactivity to vasoconstrictor agents, with NO being an important mediator of this organ dysfunction. Data in the literature have shown that hyporeactivity to catecholamines is associated with a decrease in the density of α and ß receptors in the aorta and heart, respectively, as well as an increase in GRK2 levels and that NO contributes to the increase of this kinase in sepsis . Based on this, it is hypothesized that cardiac dysfunction and decreased peripheral vascular resistance observed in sepsis may result from an increase in GRK2 activity and/or expression and its inhibition may be a relevant therapeutic target in septic shock patients. Based on this line, a measurable clinical benefit of paroxetine through the regulation of GRK2 expression in patients with septic shock is postulated.

Conditions

• Septic Shock
• Sepsis

Interventions

Type	Name	Description
DRUG	Paroxetine	Paroxetine, 40mg/day, once a day, for 05 consecutive days or 24 hours after shock resolution

Timeline

• Start date: 2023-06-10
• Primary completion: 2025-03-15
• Completion: 2025-04-15
• First posted: 2023-02-13
• Last updated: 2025-01-06

Locations

2 sites across 1 country: Brazil