Effects of Levosimendan in patients being weaned from venoarterial extracorporal membrane oxygenation. A randomized controlled investigator driven phase II trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- • Change in left ventricular outflow tract velocity time integral measured by Doppler echocardiography from baseline to 72h after initiation ECMO or before cessation of ECMO support, whichever occurs first
研究概览
简要总结
The objective of this trial is to assess the efficacy of Levosimendan in improving indices of cardiac output and pulsatile flow, thus facilitating weaning from ECMO.
Primary outcome: Change in left ventricular outflow tract velocity time integral measured by Doppler echocardiography from baseline to 72h after initiation ECMO or before cessation of ECMO support, whichever occurs first
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years; • Undergoing ECMO for cardiogenic shock or refractory cardiac arrest
排除标准
- •Coma with fixed dilatation of pupils that was not induced by drugs or other circumstances indicating likely futility • Mechanical cause of cardiogenic shock (e.g., ventricular septal defect or papillary muscle rupture) • Onset of shock more than 12 hours before screening • Massive pulmonary embolism • Severe peripheral arterial disease precluding insertion of ECMO cannula • Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation) • Age > 90 years • Severe concomitant disease associated with a life expectancy of less than 6 months • Pregnant women
结局指标
主要结局
• Change in left ventricular outflow tract velocity time integral measured by Doppler echocardiography from baseline to 72h after initiation ECMO or before cessation of ECMO support, whichever occurs first
• Change in left ventricular outflow tract velocity time integral measured by Doppler echocardiography from baseline to 72h after initiation ECMO or before cessation of ECMO support, whichever occurs first
次要结局
- Change in pulse pressure from baseline to 72h after initiation of ECMO or before cessation of ECMO support, whichever occurs first; ECMO weaning failure, defined as death during ECMO support, death within 24 h after ECMO removal or need for reimplantation of ECMO within 24 h. All cause mortality at 28 days, Urinary output for the first 48 hours post cessation of ECMO support, Central venous saturation at 4, 8, 12, 24 and 48 hours post cessation of ECMO support, Total days requiring ECMO
研究者
Dr. Robert Zilberszac
Scientific
Medical University Of Vienna