itric Oxide during Cardio Pulmonary Bypass during surgery for congenital heart defects: A Randomised Controlled Trial. - Nitric Oxide during Cardio Pulmonary Bypass in CHD

ady Cilento Children's Hospital0 个研究点目标入组 1,470 人开始时间: 2019年2月25日最近更新: 2019年6月30日

适应症

试验速览

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•- All infants and children < 2 years of age undergoing open heart surgery on CPB
•- Elective cardiac surgery and consent of parents/guardian.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 200
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Signs of persistently elevated pulmonary vascular resistance preoperatively requiring iNO or preoperative use of intravenous drugs involved in the NO pathway such as GTN, within 48 hours prior to CPB.
•- Patient is on ECLS prior to surgery
•- Concurrent known confirmed bacterial sepsis/septic shock, diagnosed within <48 hours prior to surgery and being actively treated with antibiotics at time of surgery (suspected sepsis treated with antibiotics is not an exclusion criteria unless inotropes are required for
•treatment of septic shock at time of surgery)
•- Preoperative acute respiratory distress syndrome requiring HFOV ventilation <48 hours of surgery
•- Patient requires high doses of vasoactive drugs prior to surgery with an inotrope score =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).
•- Cardiac arrest within one week (7d) prior to surgery
•- Emergency cardiac surgery which may preclude obtaining informed consent (defined as acutely required life-saving procedure in a patient unlikely to survive the next hours without the surgery)
•- Pre-existing methaemoglobinemia (MetHb>3%)

发起方

ady Cilento Children's Hospital