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

niversitair Medisch Centrum Utrecht0 个研究点目标入组 82 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•- All infants and children < 2 years of age undergoing open heart surgery on CPB
•- Elective cardiac surgery and consent of parents/guardian.

•- 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%)X*t)
•Strongly suspected or confirmed COVID-19

发起方

niversitair Medisch Centrum Utrecht