Effects of Paroxetine on Cardiovascular Function in Septic Patients
- Registration Number
- NCT05725837
- Lead Sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 92
- Patient over 18 years of age;
- Patient diagnosed with septic shock for less than 48 hours and using a minimum dose of noradrenaline (0.01 mcg/kg/min);
- Patients and/or legal guardians who consented to participate in the study through the free and informed consent term before randomization.
- Pregnant women;
- Patients with inability to use the gastrointestinal tract;
- Patients with known intolerance to paroxetine and/or fluoxetine;
- Patients on concomitant use of medications that may potentiate the occurrence of serotonin syndrome (tramadol, citalopram, escitalopram, sertraline, desvenlafaxine, venlafaxine, duloxetine, sibutramine, bupropion, amitriptyline, nortriptyline, lithium);
- Patients in end-of-life care or with an expected survival of less than 24 hours at the time of eligibility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Paroxetine 40mg, single dose a day, by mouth or enteric tube Paroxetine Paroxetine 40mg, single dose a day, by mouth or enteric tube
- Primary Outcome Measures
Name Time Method Time to vasopressor discontinuation 28 days of enrollment Discontinuation of all vasopressors for at least 48 consecutive hours
- Secondary Outcome Measures
Name Time Method Mortality during ICU stay 90 daus Mortality in the ICU
Total sequential organ failure assessment score score variation 24 to 120 hours after randomization 120 hours Variation of the total sequential organ failure assessment score score between baseline daily until 120 hours later. Total sequential organ failure assessment score varies between 0 and +24 points, higher scores meaning worse organ dysfunction
Variation in cardiovascular sequential organ failure assessment score score 24 to 120 hours after randomization 120 hours Variation of the cardiovascular sequential organ failure assessment score score between baseline daily until 120 hours later. Cardiovascular sequential organ failure assessment score varies between 0 and +4 points, higher scores meaning worse cardiovascular dysfunction
Cumulative vasopressor dose for 120 hours after randomization 120 hours Dose of infused norephineprine and/or vasopressin during 120 hours after randomization
Length of stay in the ICU 90 days time spent in ICU
Cumulative vasopressor dose in the first 48 hours after randomization Translation results Cumulative vasopressor dose in the first 48 hours after randomization 48 hours Dose of infused norephineprine and/or vasopressin during the first 48 hours after randomization
Trial Locations
- Locations (2)
Hospital São José
🇧🇷Criciúma, Santa Catarina, Brazil
Hospital Maternidade São José de Colatina
🇧🇷Colatina, Espirito Santo, Brazil