Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients

Instituto do Cancer do Estado de São Paulo250 enrolled

Overview

Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock. The aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

250

Conditions

Septic Shock

Interventions

VasopressinDRUG

Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

NorepinephrineDRUG

Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Solid neoplasm needing ICU * Septic Shock according standard criteria Exclusion Criteria: * Younger than 18 years; * Pregnancy; * Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis; * Severe hyponatremia (Na\<130mEq/L); * Acute mesenteric ischemia; * Acute myocardial infarction; * Cardiogenic shock; * Current use of vasopressor before randomization * Expected ICU stay less than 24 hours * Enrolled in another study; * Refusal to consent.

Locations (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, Sao Paulo/SP, Brazil

Outcomes

Primary Outcomes

28-day mortality

Mortality from all causes in 28-day follow-up

Time frame: 28-day from randomization

Secondary Outcomes

90-days mortality

Mortality from all causes 90 days after randomization

Time frame: 90 days after randomization

Days alive and free of mechanical ventilation

Days alive and free of mechanical ventilation at 28-day follow-up

Time frame: 28 days after randomization

Days alive and free of vasopressors

Days alive and free of any type of vasopressor agent at 28-day follow-up

Time frame: 28 days after randomization

Days alive and free of renal replacement therapy

requirement of dialysis of hemofiltration at 28-day follow-up

Time frame: 28 days after randomization

SOFA score in 24 hours

Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization.

Time frame: 24 hours after ICU admission

SOFA score in 96 hours

Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.

Time frame: 96 hours after randomization

Data from ClinicalTrials.gov

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