ACTRN12617000821392已完成2 期
In infants and children < 2 years of age with congenital heart defects, what is the effect of Nitric Oxide during open heart surgery with Cardio Pulmonary Bypass on postoperative length of mechanical ventilation? - A Randomised Controlled Trial.
A/Prof Andreas Schibler0 个研究点目标入组 1,371 人开始时间: 2017年6月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,371
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- Days 至 2 Years（—）
- 性别
- All
入选标准
- •All infants and children < 2 years of age undergoing elective open heart surgery on CPB, and consent of parents/guardian.
排除标准
- •1. Signs of persistently elevated pulmonary vascular resistance preoperatively requiring iNO or preoperative use of drugs involved in the NO pathway such as GTN within 48 hours prior to CPB (oral sildenafil treatment alone is not an exclusion)
- •2. Patient is on ECLS immediately prior to surgery
- •3. Receiving ongoing treatment with antimicrobials for confirmed or suspected sepsis or septic shock diagnosed within 48hours prior to the time of surgery
- •4. Preoperative acute respiratory distress syndrome requiring HFOV ventilation within 48 hours prior to surgery
- •5. Patient requires high doses of vasoactive drugs prior to surgery with a score equal or greater than 15 met within 24 hours prior to surgery: Inotrope requirement will be calculated by means of the Vasoactive-Inotrope Score (VIS) (2): VIS = dopamine dose (mcg/kg/min) + dobutamine dose (mcg/kg/min) + 100 x adrenaline dose (mcg/kg/min) + 100 x noradrenaline dose (mcg/kg/min) + 10 x milrinone dose (mcg/kg/min) + 10,000 x vasopressin dose (U/kg/min).
- •6. Cardiac arrest within one week (7d) prior to surgery
- •7. Emergency cardiac surgery (defined as acutely required life-saving procedure in a patient unlikely to survive the next 48hours without the surgery)
- •8. pre-existing methaemoglobinemia (MetHb>3%)
- •9. Patients that were previously enrolled and randomized into the study with surgical procedure performed that required use of cardio-pulmonary bypass will not get re-randomized. Previously enrolled and randomized patients will undergo the same treatment allocation for subsequent surgeries, unless parents opt out.
- •10. Chronic ventilator dependency
研究者
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