Actively Recruiting
Effects of Paroxetine on Cardiovascular Function in Septic Patients A Randomized Placebo Controlled Trial
Led by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude · Updated on 2025-01-06
92
Participants Needed
2
Research Sites
96 weeks
Total Duration
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AI-Summary
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 constrict blood vessels, with nitric oxide playing a key role in this problem. Research shows that reduced response to certain medications is linked to changes in specific receptors and increased levels of a protein called GRK2, which nitric oxide helps raise. This study explores the idea that heart and blood vessel problems in sepsis may be caused by higher GRK2 activity, and that blocking this protein could be an effective treatment. The trial is evaluating paroxetine, given at a dose of 40 mg once daily for five days or until 24 hours after the shock resolves. Participants with septic shock will receive this medication or a placebo in a randomized, controlled setting to assess its effects on cardiovascular function. The study is a Phase 2 clinical trial designed to test whether paroxetine can regulate GRK2 expression and improve outcomes in septic shock. Participants will be followed for up to 28 days after enrollment, with the main measurement being the time until vasopressor medications can be stopped. Researchers will monitor heart and blood vessel function, drug usage, and overall health during this period. The study includes careful observation of safety and effectiveness to better understand paroxetine's potential role in treating septic shock.
CONDITIONS
Official Title
Effects of Paroxetine on Cardiovascular Function in Septic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
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Trial Site Locations
Total: 2 locations
1
Hospital Maternidade São José de Colatina
Colatina, Espírito Santo, Brazil
Actively Recruiting
2
Hospital São José
Criciúma, Santa Catarina, Brazil, 88801460
Actively Recruiting
Research Team
F
felipe dal-pizzol, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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