Effect of Milrinone Versus Placebo on Hemodynamics in Patients With Septic Shock; Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- The change of cardiac output from baseline (before study drug administration) to 6 hours (during study administration)
研究概览
简要总结
Sepsis is one of the most serious healthcare problems, worldwide, and financial burdens.
The overall mortality of severe sepsis/septic shock was 44.5-52.6%. A common cause of death is refractory shock and multi-organ failure. Myocardial dysfunction is a relatively common complication of septic shock. This causes a decrease in the amount of cardiac output, resulting in insufficient blood supply to the organ and multi-organ failure and lead to death Early goal-directed therapy began to use dobutamine in patients with septic shock Sepsis Survival Campaign Guideline 2016 recommended drug is dobutamine and an alternative drug is milrinone in septic shock patients with clinical signs of poor tissue perfusion.
详细描述
According to several studies, the use of dobutamine increases the amount of cardiac output but it has also been reported to increase mortality rates too. There are few studies of milrinone in patients with septic shock.
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)
盲法说明
Pharmacist who does not involve in patient enrollment nor treatment will prepared milrinone or placebo in the identical container, before the study drug will be given to patients, according to their treatment arm.
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
- •Patients ≥ 18 years old
- •Diagnosis Septic Shock from the definition of SEPSIS III in intensive care unit at Siriraj hospital and Hat-Yai hospital
- •Receive fluid resuscitation at least 30 ml/kg and/or Vasopressor until mean arterial pressure ≥ 65 mmHg
- •Persistence lactate >2mmol/L at 6th hour after resuscitation
- •Urine output < 0.5 ml/kg at 6th hour after resuscitation
- •Left ventricular ejection fraction (LVEF) < 40 %
排除标准
- •Chronic kidney disease stage 5 and denied renal replacement therapy
- •Life-threatening tachyarrhythmia before enrolled e.g. Ventricular tachycardia, Ventricular fibrillation
- •Patient sign do-not-resuscitation and terminally ill
研究组 & 干预措施
Milrinone group
The pharmacist prepares milrinone 20 mg with normal saline solution (NSS) 100 ml then starts dose 0.5 mg/kg/min for up to 12 hours. The doctor performs Echocardiogram before start Milrinone, during infusion, and after 12 hours from stop Milrinone. Other medications or interventions were used or not used depending on own doctor.
干预措施: Milrinone (Drug)
Placebo group
The pharmacist uses 100 ml of NSS, packed out in the same format, dose, and administration of the drug were exactly the same as in the milrinone group. The doctor performs Echocardiogram same time as the milrinone group
干预措施: Milrinone (Drug)
结局指标
主要结局
The change of cardiac output from baseline (before study drug administration) to 6 hours (during study administration)
时间窗: upto 24 hours
by echocardiogram or Pulse contour analysis or Thermodilution technique from pulmonary artery catheter
次要结局
- 28-day mortality(upto 28 days)
- Intensive care unit (ICU) mortality(upto 120 days)
- Hospital mortality(upto 120 days)
- Dose of vasopressor after intervention(upto 7 days)
- Lactate clearance(upto 7 days)
- Mechanical ventilator free day(upto 28 days)
- Extracorporeal membrane oxygenation (ECMO) or Renal replacement therapy (RRT)(upto 28 days)
- Incident of tachyarrhythmia(upto 28 days)