Clinical trial NCT03483753: Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery
Official title: Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery: a Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Circulatory Shock
Non-cardiac Surgery
Keywords: Vasopressin
Norepinephrine
Post-operative
Critical Care
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.)

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years;
* Patients undergoing high-risk non-cardiac surgery;
* vasopressor need within 24 hours after surgery, defined as mean arterial pressure (MAP) \<65 mmHg after volume resuscitation with at least 1 liter of crystalloid solution (Ringer's lactate) and maintaining a cardiac index\> 2.2 ml / min / m²;
* Signature of the informed consent form.

Exclusion Criteria:

* Allergy to vasoactive drugs;
* Previous use of vasopressor;
* Gestation;
* Presence of Raynaud's phenomenon, altered Allen's test, systemic sclerosis or vasospastic diathesis;
* Severe hyponatremia (Na \<130 mEq / L);
* Acute mesenteric ischemia;
* Acute coronary syndrome;
* Participation in another study;
* Refusal to participate in the study.

Primary outcomes:
measure: Incidence between groups of a composite outcome of all-cause mortality, cardiovascular and renal complications after high-risk non-cardiac surgeries
timeFrame: 30 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days after randomization
measure: Acute myocardial infarction
timeFrame: 30 days after randomization
measure: Cardiogenic shock
timeFrame: 30 days after randomization
measure: Ventricular and / or supraventricular arrhythmia
timeFrame: 30 days
measure: Acute respiratory distress syndrome (ARDS)
timeFrame: 30 days
measure: Stroke and transient ischemic attack
timeFrame: 30 days
measure: Delirium
timeFrame: 30 days
measure: Acute renal failure (AKIN 1 or more)
timeFrame: 30 days
measure: Length of time in the Intensive Care Unit (ICU) and hospital
timeFrame: 30 days
measure: Length of mechanical ventilation
timeFrame: 30 days
measure: Septic shock
timeFrame: 30 days
measure: hospital and ICU readmission rate
timeFrame: 30 days
measure: Reoperation
timeFrame: 30 days
measure: Incidence of severe adverse events
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Juliano P Almeida, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Tais F Szeles, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Russell JA. Vasopressin, Norepinephrine, and Vasodilatory Shock after Cardiac Surgery: Another "VASST" Difference? Anesthesiology. 2017 Jan;126(1):9-11. doi: 10.1097/ALN.0000000000001435. No abstract available.
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