Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery: a Randomized and Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Incidence between groups of a composite outcome of all-cause mortality, cardiovascular and renal complications after high-risk non-cardiac surgeries
研究概览
简要总结
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.
详细描述
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.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vasopressin group
Blinded vasopressin
干预措施: Vasopressin (Drug)
Norepinephrine group
Blinded norepinephrine
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Incidence between groups of a composite outcome of all-cause mortality, cardiovascular and renal complications after high-risk non-cardiac surgeries
时间窗: 30 days
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.
次要结局
- Length of time in the Intensive Care Unit (ICU) and hospital(30 days)
- All-cause mortality(30 days after randomization)
- Ventricular and / or supraventricular arrhythmia(30 days)
- Acute respiratory distress syndrome (ARDS)(30 days)
- hospital and ICU readmission rate(30 days)
- Stroke and transient ischemic attack(30 days)
- Acute renal failure (AKIN 1 or more)(30 days)
- Reoperation(30 days)
- Incidence of severe adverse events(30 days)
- Acute myocardial infarction(30 days after randomization)
- Cardiogenic shock(30 days after randomization)
- Delirium(30 days)
- Length of mechanical ventilation(30 days)
- Septic shock(30 days)
研究者
Tais Felix Szeles
PhD student
University of Sao Paulo