Paroxetine Treatment to Improve Heart and Blood Vessel Function in Adults with Septic Shock A Randomized, Placebo-Controlled Phase 2 Study

What this Trial Is About

Septic shock is a serious condition marked by low blood pressure, reduced resistance in blood vessels, and poor response to drugs that tighten blood vessels. This condition involves nitric oxide affecting organ function, and researchers believe that changes in certain heart and blood vessel receptors, along with increased GRK2 enzyme activity, contribute to these problems. The study explores whether blocking GRK2 activity with paroxetine might improve heart and blood vessel function in patients with septic shock. Participants will be randomly assigned to receive either paroxetine or a placebo. Paroxetine is given as a 40 mg dose once daily by mouth or through an enteric tube for up to five days or until the shock resolves. The study is designed as a randomized, placebo-controlled trial with quadruple masking to evaluate the effects of paroxetine on cardiovascular function during septic shock. During the study, researchers will monitor how long it takes for patients to stop needing vasopressor drugs over 28 days. They will also track the total doses of vasopressors used in the first two and five days, changes in organ failure scores related to the heart and circulation, length of stay in the intensive care unit, and mortality during ICU stay. Patients will be closely assessed for these outcomes to understand paroxetines impact on septic shock recovery.

Effects of Paroxetine on Cardiovascular Function in Septic Patients