Prophylactic Milrinone Infusion for the Prevention Low Cardiac Output Syndrome After Corrective Surgery for Congenital Heart Disease in Infants: A Randomized, Multi-center, Double-blinded, Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Number of participants died within 30 days postoperatively
研究概览
简要总结
This randomized, multi-center, double-blinded, placebo-controlled study is designed to evaluate the efficacy and safety of milrinone compared with placebo in participants after corrective surgery for congenital heart disease. Participants will be randomized in a 1:1 ratio within 90 minutes after arriving in the intensive care unit (ICU), to receive either intravenous milrinone or placebo for 36 hours. Participants will be stratified according Vasoactive Inotrope Score after arriving in the ICU.
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
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age younger than 12 months
- •Without pre-operative low cardiac output syndrome
- •Bi-ventricular repair of congenital heart disease involving cardiopulmonary bypass
- •Informed consent obtained from each participant's parent or guardian
排除标准
- •A body weight <2 kg
- •Prematurity (birth <36 weeks postconceptual age)
- •Renal dysfunction ( Creatinine>1.5mg/dL 48 hours before surgery)
- •Low cardiac output syndrome or hypotension on arrival to ICU from OR
- •Cardiopulmonary resuscitation before surgery
- •Platelet count<80,000/mm3 before surgery
- •Left ventricular outflow tract obstruction before surgery
- •Ventricular arrhythmia before surgery
- •Without femoral artery catheter before arriving in the ICU
- •Consent was withdrawn by participants' parent or guardian.
研究组 & 干预措施
milrinone
milrinone milrinone will be administered intravenously at a rate of 0.75ug/kg/min for 35 hours, and baseline catecholamines will be administered at the discretion of the physician.
干预措施: Milrinone (Drug)
normal saline
placebo placebo (normal saline) will be administered intravenously for 35 hours, and baseline catecholamines will be administered at the discretion of the physician.
干预措施: Normal saline (Drug)
结局指标
主要结局
Number of participants died within 30 days postoperatively
时间窗: up to 30 days postoperatively
Number of participants developed low cardiac output syndrome within the first 36 hours after initiation of study drug
时间窗: 36 hours after initiation of study drug
Low cardiac output syndrome was defined as the following: clinical signs or symptoms (eg, tachycardia, oliguria, poor perfusion, or cardiac arrest) with or without a widened arterial-mixed venous oxygen saturation difference or metabolic acidosis; mechanical support of the circulation (eg, extracorporeal life support, ventricular assist device), a cardiac index determined by Pulse indicator continuous cardiac output (PiCCO) of \<2.2 L/min/m2
次要结局
- Change in Vasoactive Inotrope Score.(36 hours after initiation of study drug)
- Length of intensive care stay.(up to 30 days postoperatively or until ICU discharge.)
- Number of participants with improvement of ventriculoarterial coupling(36 hours after initiation of study drug)
- Length of hospital stay.(up to 30 days postoperatively or until hospital discharge)
- Number of participants developed low cardiac output syndrome in the interval between 36 hours after initiation of study drug and the final Follow up. Cardiac index will be determined by Doppler echocardiography(up to 30 days postoperatively)
- Duration of mechanical ventilation.(up to 30 days postoperatively or until extubation)
- Number of participants requiring mechanical circulatory support.(up to 30 days postoperatively)
- Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline.(36 hours after initiation of study drug)
- Number of participants with treatment-related adverse events(36 hours after initiation of study drug)