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NCT Number: NCT05725837

Effects of Paroxetine on Cardiovascular Function in Septic Patients

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Maternidade São José de Colatina, Colatina, Espírito Santo, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paroxetine

Drug

Paroxetine, 40mg/day, once a day, for 05 consecutive days or 24 hours after shock resolution

Primary outcomes

  1. Time to vasopressor discontinuation

    Time frame: 28 days of enrollment

    Discontinuation of all vasopressors for at least 48 consecutive hours

Secondary outcomes

  1. Cumulative vasopressor dose in the first 48 hours after randomization Translation results Cumulative vasopressor dose in the first 48 hours after randomization

    Time frame: 48 hours

    Dose of infused norephineprine and/or vasopressin during the first 48 hours after randomization

  2. Variation in cardiovascular sequential organ failure assessment score score 24 to 120 hours after randomization

    Time frame: 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

  3. Cumulative vasopressor dose for 120 hours after randomization

    Time frame: 120 hours

    Dose of infused norephineprine and/or vasopressin during 120 hours after randomization

  4. Total sequential organ failure assessment score score variation 24 to 120 hours after randomization

    Time frame: 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

  5. Length of stay in the ICU

    Time frame: 90 days

    time spent in ICU

  6. Mortality during ICU stay

    Time frame: 90 daus

    Mortality in the ICU

Other outcomes

  1. Neutrophilic levels of total and phosphorylated GRK2

    Time frame: 120 hours

    Expression of GRK-2 measured by western blot in isolated neutrophils

  2. Plasma levels of cytokines and chemokines

    Time frame: 120 hours

    Plasma levels of different cytokines and chemokines measured by ELISA

  3. Internalization of CXCR2 receptors in neutrophils

    Time frame: 120 hours

    Internalization of receptors known to be influenced by GRK-2 inhibitor by flow cytometry

Study contacts

Contact information is provided by the study sponsor or research team.

felipe dal-pizzol, MD

CONTACT

[email protected]

+55 48 991852300

Sponsors and collaborators

Lead sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Other

Registry information

Official study title

Effects of Paroxetine on Cardiovascular Function in Septic Patients: a Randomized Placebo Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2023
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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