inflammation after congenital heart surgery
Conditions
Interventions
Patients allocated to the study intervention arm will receive NO, which will be
blended into the fresh gas flow kept at 3L/min for the CPB oxygenator with NO
levels maintained at 20 ppm via a NO-A n
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: - All infants and children
Exclusion criteria
Exclusion criteria: - 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 =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of mechanical ventilation as defined as the duration of respiratory support for all episodes with an endotracheal tube in situ for the first 28 days post randomisation. The outcome will be reported using ventilator free days (VFD). A systematically zero value will be assigned for patient who die to allow important weight to death as the most pejorative outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of LCOS, need for ECLS, and Mortality - The length of stay in PICU, hospital length of stay and health care costs - Levels of systemic inflammatory markers and levels of markers of myocardial injury (in patients with biobanking) - Platelet function and levels of markers for platelet activation prior, during, and after CPB - Extent of new and worsened ischemic white matter changes on cerebral MRI. LCOS is defined as the inability of the myocardium to provide adequate oxygen delivery (DO2) to the tissue. DO2 measurements are not feasible in daily practice, hence accepted surrogate measures are commonly used. For the purpose of this study, LCOS will be defined as: blood lactate level greater than 4 mmol/l with a mixed venous saturation level less than 60% in a fully corrected heart (or the SaO2-SvO2 gradient >35% in uncorrected lesion) within the first 48 hours postoperatively and/or high inotrope requirement: 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). A score >=15 indicating low cardiac output syndrome. Platelet function will be evaluated using the PACT diagnostic tool. PACT is a platelet function test based on flow cytometry. The test determines the reactivity of individual platelets in response to agonist like thrombin, ADP, and thromboxane A2. Reactivity is quantified by determining degranulation, measured as P-selectin expression on the platelet surface, as well as activation of integrin aIIbβ3, determined as binding of fibrinogen to the platelets. It analyses platelet function through standardized flow cytometric assessment of platelet activation markers using nanobodies. Its nanobody-based technology allows for simultaneous assessment of multiple platelet ac | — |
Countries
Netherlands
Outcome results
None listed