Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS): a Prospective Randomized Double-blinded Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Vasopressors-free days
研究概览
简要总结
Vasoplegia is an important determinant for adverse postoperative outcome and is observerd in 5% to 54% of patients undergoing cardiac surgery using cardiopulmonary bypass (CPB).
Postoperative vasoplegia is defined as a state with low systemic vascular resistance despite a normal or high cardiac output, and the need for vasopressor therapy.
Steroids attenuate the inflammatory response to cardiopulmonary bypass,but their effect on clinical outcomes is uncertain.
This is a double-blinded, randomized, clinical trial designed to determine the efficacy of low dose corticosteroid infusion in vasopressor free-days in vasoplegia after cardiac surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Cardiac surgery with cardiopulmonary bypass
- •Norephinerine treatment in ICU with dose great or equal than 0,1 mcg/kg/min to maintain or restore a MAP over 70 mmHg for at least 30 minutes within 24 hours after surgery
排除标准
- •Preoperative vasopressor use (within 72 hours prior to surgery)
- •Preoperative steroids use (within 7 days prior to surgery)
- •Presence of ventricular assist device other than intraaortic ballon pump
- •Transplant procedures
- •Emergency procedures
- •Aortic repairs
- •Congenital procedures
- •Endocarditis
- •Bacterial or fungal infection in the preceding 30 days
- •Active neoplasia
- •Pregnancy
- •Recent history of gastrointestinal bleeding
- •Allergy or intolerance to steroids
- •Participation in other study
研究组 & 干预措施
Steroid
Patients assigned for steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.
干预措施: hydrocortisone sodium succinate (Drug)
Control
Patients assigned for control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.
干预措施: Saline (Drug)
结局指标
主要结局
Vasopressors-free days
时间窗: 30 days
Days free of vasopressors up to day 30
次要结局
- 30 days mortallity(30 days)
- ICU length of stay(30 days)
- Infection complication(30 days)
- Acute myocardial infarction(30 days)
- Atrial fibrillation(30 days)
研究者
Filomena R B G Galas
Associate Professor of Anesthesiology at University São Paulo Medical School
Instituto do Coracao