The purpose of the present study is to evaluate the effect of vasopressin compared to norepinephrine on the clinical complications of patients with vasospastic shock after noncardiac surgeries.
The Systemic Inflammatory Response Syndrome (SIRS) is a common complication after non-cardiac surgery, impacting negatively on patient outcome and with high incidence rates. Vasoplegic syndrome is the most serious complication of SIRS and can happen after any type of surgery. The etiology of the vasoplegic syndrome has not yet been fully elucidated, but is known to occur more frequently in patients at high surgical risk, submitted to major surgeries, or in the presence of perioperative complications and patients with comorbidities. In this circumstance, the depletion of vasopressin stocks is described, which may contribute to the refractoriness of the shock and the lack of response to the catecholaminergic drugs. The standard treatment of perioperative vasoplegia has been adequate volume replacement and administration of vasopressors, with norepinephrine being the most commonly used. However, it is known that norepinephrine may have deleterious effects on the body and in 20% of patients with vasospastic shock it is ineffective. Previous studies have suggested benefits of adding vasopressin in refractory situations, especially in septic shock. Recently the VANCS study (Vasopressin or norepinephrine in the vasopregic shock after cardiac surgery: double-blind, controlled and randomized study) demonstrated superiority of vasopressin in the reversion of vasoplegic shock after cardiac surgery, as well as a lower incidence of renal insufficiency, atrial fibrillation and shorter hospitalization time. (Anesthesiology. 2017 Jan;126(1):85-93.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement. Continuous infusion of the drug at doses ranging from 0.01 U / min to 0.06 U / min
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement. Continuous infusion of the drug at doses ranging from 0.1 mcg / kg / min to 1.0 mcg / kg / min.
Incidence between groups of a composite outcome of all-cause mortality, cardiovascular and renal complications after high-risk non-cardiac surgeries
Cardiovascular complications include: stroke, acute myocardial infarction, cardiogenic shock, nonfatal myocardial injury, and ventricular or supraventricular arrhythmias. Renal complications: Acute renal failure with AKIN stage 1 or higher or renal support therapy.
Time frame: 30 days
All-cause mortality
mortality rate of any cause
Time frame: 30 days after randomization
Acute myocardial infarction
to compare between groups the incidence of acute myocardial infarction
Time frame: 30 days after randomization
Cardiogenic shock
to compare between groups the incidence of cardiogenic shock
Time frame: 30 days after randomization
Ventricular and / or supraventricular arrhythmia
to compare between groups the incidence of Ventricular and / or supraventricular arrhythmia
Time frame: 30 days
Acute respiratory distress syndrome (ARDS)
to compare between groups the incidence of Acute respiratory distress syndrome (ARDS)
Time frame: 30 days
Stroke and transient ischemic attack
to compare between groups the incidence of Stroke and transient ischemic attack
Time frame: 30 days
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Delirium
to compare between groups the incidence of Delirium
Time frame: 30 days
Acute renal failure (AKIN 1 or more)
to compare between groups the incidence of Acute renal failure (AKIN 1 or more)
Time frame: 30 days
Length of time in the Intensive Care Unit (ICU) and hospital
Length of time in the Intensive Care Unit (ICU) and hospital
Time frame: 30 days
Length of mechanical ventilation
Length of mechanical ventilation
Time frame: 30 days
Septic shock
to compare between groups the incidence of septic shock
Time frame: 30 days
hospital and ICU readmission rate
hospital and ICU readmission rate
Time frame: 30 days
Reoperation
number of patients who required reoperation
Time frame: 30 days
Incidence of severe adverse events
to compare the incidence of severe adverse outcomes defined as mesenteric ischemia, digital ischemia, hyponatremia (Na\<130mEq/L), myocardial infarction or stroke
Time frame: 30 days