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 sites1,470 target enrollmentFebruary 25, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Congenital heart disease ranks still within the top causes of infant mortality in industrialized countries. Despite considerable advances over the past decade, the exposure to cardiopulmonary bypass (CPB), which is needed for most heart surgeries, remains responsible for major side effects: The exposure of patient blood to large artificial surfaces in the CPB circuit triggers a very strong systemic inflammatory syndrome, which leads in a third of patients to low cardiac output syndrome (LCOS).
Sponsor: ady Cilento Children's Hospital
Enrollment: 1470
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

February 25, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

ady Cilento Children's Hospital

•\- 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%)