Effects of Paroxetine on Cardiovascular Function in Septic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2025-04-15

Brief Summary

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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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Detailed Description

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Conditions

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Septic Shock Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After 20 patients randomized the advisory board will unblind subjects to determine if the fluoxetine arm should be continued. Since it is not expected to have any beneficial effect of this treatment (it is only a comparative control to the effect of paroxetine on serotonin metabolism). Based on the decision of the committee the study could exclude the serotonin arm and the definitive sample size is going to be calculated.

The fluoxetine group was removed from the study after analysis of the first 20 patients (as foreseen in the initial protocol, after 20 patients included the blind would be broken to determine the final sample size) as it did not present an apparent benefit in the primary outcome. Considering that it had been included as a comparator for the effect of paroxetine on serotonin metabolism, and no beneficial effect from its use was anticipated, the study management committee decided to withdraw it.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

40mg, single dose a day, by mouth or enteric tube

Group Type PLACEBO_COMPARATOR

Paroxetine

Intervention Type DRUG

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

Paroxetine

40mg, single dose a day, by mouth or enteric tube

Group Type EXPERIMENTAL

Paroxetine

Intervention Type DRUG

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

Interventions

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Paroxetine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No