Recruiting PHASE2 Septic Shock

New treatment option for Septic Shock

Official title Effects of Paroxetine on Cardiovascular Function in Septic Patients

ClinicalTrials.gov ID: NCT05725837

What this study is testing

What is Paroxetine?

Paroxetine is an investigational medicine, given as an once-daily, being studied as a potential treatment for septic shock.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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 .
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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 likely can't join if

  • 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...
  • Patients in end-of-life care or with an expected survival of less than 24 hours at the time of eligibility

The study team makes the final eligibility decision.

Where it's taking place

  • Colatina, Espírito Santo, Brazil
  • Criciúma, Santa Catarina, Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Colatina, Espírito Santo, Brazil; Criciúma, Santa Catarina, Brazil. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.