Effects of Paroxetine on Heart Function in Septic Patients
Effects of Paroxetine on Cardiovascular Function in Septic Patients: a Randomized Placebo Controlled Trial
This study is testing if the medication paroxetine can help improve heart function in adults who are experiencing septic shock.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude Academic / other |
| Locations | 2 sites (Colatina, Espírito Santo and 1 other locations) |
| Trial ID | NCT05725837 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of paroxetine on cardiovascular function in patients experiencing septic shock. The study hypothesizes that paroxetine may improve cardiac dysfunction and vascular resistance by regulating the expression of GRK2, a kinase associated with sepsis. Eligible participants are adults diagnosed with septic shock within 48 hours and receiving noradrenaline. The trial aims to assess the potential therapeutic benefits of paroxetine in this critical patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with septic shock for less than 48 hours.
Not a fit: Patients who are pregnant, unable to use the gastrointestinal tract, or have a life expectancy of less than 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve heart function and vascular response in patients suffering from septic shock.
How similar studies have performed: While this approach is based on existing literature regarding GRK2 and sepsis, the specific use of paroxetine in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Colatina, Espírito Santo and 1 other locations
- Hospital Maternidade São José de Colatina — Colatina, Espírito Santo, Brazil (Recruiting)
- Hospital São José — Criciúma, Santa Catarina, Brazil (Recruiting)
Study contacts
- Study coordinator: felipe dal-pizzol, MD
- Email: fdpizzol@gmail.com
- Phone: +55 48 991852300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.