itric oxide administration in the heart-lung machine during surgery for heart defects

Phase 1

• 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).; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2017-004684-12-NL
• Lead Sponsor: ady Cilento Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1470

Inclusion Criteria

- 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

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 <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%)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified